ICON plc logo
ICON plc

ICON plc, or simply ICON, is a global provider of outsourced development services to companies in industries like biotechnology, medical devices, and pharmaceut

Clinical Research Associate II

Location

Singapore

Posted

73 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

Clinical Research Associate II

ICON plc

Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing - Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. - Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. - Collaborating with investigators and site staff to facilitate smooth study conduct. - Performing data review and resolution of queries to maintain high-quality clinical data. - Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile - Bachelor's degree in a scientific or healthcare-related field. - Minimum of 2 years of experience as a Clinical Research Associate. - In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. - Strong organizational and communication skills, with attention to detail. - Ability to work independently and collaboratively in a fast-paced environment. - Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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Full TimeRemoteTeam 10,001+Since 1924H1B No Sponsor

Title: Grants & Contracts Administrator - Clinical Research Administration Finance Post-Award-Fully Remote Location: North Carolina Job Description: School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations. Step into a high‑impact, fully remote role managing critical industry sponsored clinical research grants and contracts! Be You. You will effectively manage assigned projects and financial project portfolios using independent judgment and discretion to make decisions that impact the compliance and successful completion of the clinical research studies. You will build and maintain close collaborative working relationships with the Principal Investigators (Pls), key study personnel and colleagues throughout Duke to effectively manage the financial activities of research studies. This position will be located within the School of Medicine Shared Research Administration Resource Group and will play an active role in working with specifically identified departments to manage their portfolio of grants and contracts. This position is responsible for managing and overseeing an assigned portfolio of complex grants and contracts using knowledge of grant and contract management rules and regulations, technical expertise, and analytical skills. Pre-award activities include support for clinical research, including trials, for PI initiated and Sponsor initiated studies, for multiple clinical research programs. Ensure all applications and contracts meet sponsor/agency and university guidelines adhering to the necessary internal and external deadlines. Post-award activities include detailed reconciliation of assigned project budgets, preparing complex budget reports, preparing adjustments and corrections in assigned project budgets for further review and approval in order to meet project goals and federal requirements. Work Arrangement - Fully Remote All Duke University remote workers must reside in one of the following states or districts: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington (State), Washington, DC. DEPARTMENTAL PREFERENCES Successful candidates will have previous clinical research administration experience and/or pre-award AND post-award administrative and financial experience. Research or grants education and/or certification is preferred. Pre-award and post award experience preferred. MINIMUM QUALIFICATIONS Education/Training - Work requires communications, analytical and organizational skills generally acquired through completion of a bachelor's degree program. Successful completion of Financial Services Introduction to R3, Introduction to Duke GL, Introduction to Accounting, Sponsored Research Reporting, Research Administration at Duke (online), Basic Compliance (online), Duke Human Research Training (online), Budget Development and Negotiation Training, and Industry Funded Clinical Research—Process for Contracts within first six months of hire is required. Successful completion of the Research Administration Academy (RAA) is expected. Employees hired into this classification without RAA training will work closely with their manager to schedule and complete the training within 12 months of start date. The expectation is that the staff member will maintain the requirements for their level. Failing to meet these requirements will be addressed through the performance review process. Upon successful completion of expected training, the employee must maintain certification(s) by completing continuing education requirements. Experience - No experience required for candidates who possess a Bachelor's or Master's degree in a field of study directly related to the specific position. Be Bold. Skills - Ability to analyze data and formulate conclusions. - Ability to learn changing technologies related to grants and contracts management. - Proficient use of computers; requires solid working knowledge of MS Office Suite (Word, Access, Excel, Power Point). - Ability to communicate both verbally and in writing with all levels of the organization. - Ability to manage and prioritize multiple projects/tasks simultaneously. - Ability to create verbal and written reports. - Knowledge of federal rules and regulations relating to research grant and/or contract activity. - Knowledge of Duke University policies and procedures relating to grant and contracts activity. - Knowledge of Duke University processes, systems and offices related to and/or involved in grant and contract submission and management. - Understand and be able to apply federal and university rules to management of effort allocation for individuals compensated whole or in part from federal awards. - Understand and be able to apply costing rules and regulations to federally funded projects. - Experience with/Ability to perform required functions in SPS, R3, grants.duke and SES relating to assigned duties. - Understand financial processes and controls including the reconciliation process. Work Performed Pre-award Job Responsibilities - Develop budgets and budget justification in collaboration with PI/Research Team which include proofing the budget for inconsistencies, ensuring accuracy and compliance with study protocol. - Arrange and participate in budget discussions. - Prepare and submit grants and contracts through pre-award process utilizing both Sponsor and Duke regulations. Follow through to submission to Sponsor. - Submit contracts through the SPS system for approval. Ensure receipt of sponsor signatures on final agreement. - Advise the faculty/PI on administrative requirements in preparing proposal submissions. - Assist faculty/PI and study team with development of internal cost assessment including the use/implementation of the Clinical Research Management System, if applicable. - Obtain management approval on external and internal budgets before sending to the sponsor for review. - If required prepare, coordinate and review proposal elements such as biosketches, justifications and facilities & resources for consistency, accuracy, and completeness. - Monitor compliance with agency and University regulations regarding submission; verify all financial information, including the application of the appropriate overhead rate for the project. - Negotiate budget and payment terms with the approval from the Principal Investigator, research team and Grants and Contracts Manager. - Review informed consent to ensure it is consistent with the budget and financial terms outlined in the agreement. - Interpret contractual payment terms and prepare final contract and associated budget and documents for initial invoice. 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Transfer any residuals in accordance with Departmental and School of Medicine (SOM) policy. - Work closely with the study team to manage effort and make adjustments as needed to ensure that funding sources are properly aligned with the effort of faculty and study staff, while maintaining compliance with funding agencies policies. - Monitor proposal and contract status and advise faculty/PI on requirements and deadlines associated with research protection protocols. - Reconcile monthly budget reports and inform faculty/PI and/or supervisor of potential corrections/adjustments that have been made. - Monitor compliance with agency and University regulations regarding reporting. - Maintain financial records per the institutional documents’ retention guidelines. Administrative Job Responsibilities - Produce reports and fiscal forecasts for the study team regularly during the study with enough detail for study teams to make informed decisions about their research portfolio, Hub accounts and funds available to support effort and other expenses. - Develop project management plan for review by the faculty/PI or senior level grants administrator. - Serve as primary liaison with sponsors, study personnel and PIs. Collaborate, and communicate with other study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Refer more complex questions and escalate issues to others as appropriate. - Interpret departmental policies and procedures, making decisions on specific operating problems and issuing instructions on behalf of unit. - Apply federal and university rules to appropriately manage effort for individuals compensated, in whole or in part, from sponsored awards. - Submit reports to the Divisional Administrator/Business Manager/Leadership when requested. Tier Structure Associate: Proficient as a grants and contracts administrator. Advanced: Experienced, highly capable, and requires minimal oversight of work. Experience - 3 years of relevant experience (2 years for internal employees who have received 2 Exceeds Expectations on performance reviews). Training - RAA required in addition to 2 electives to prepare for AGM is required. AGM must be completed within 12 months. Senior: Subject matter expert. May be responsible for mentoring and developing others. Experience - 6 years of relevant experience (5 years for internal employees who have received 4 Exceeds Expectations on performance reviews. CRA certification can also reduce the years of experience requirement to 5 years). Training - RAA and AGM required. Expected to attend all the appropriate internal updates. Lead: Advanced tier competencies as well as responsibilities for mentoring and developing staff. Oversees work of others. May or may not carry same responsibilities as a full supervisor. Experience - 3 years of relevant experience (2 years for internal employees who have received 2 Exceeds Expectations on performance reviews). Training - RAA and AGM required. Expected to attend all the appropriate internal updates. The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description. Choose Duke. Apply now to join a team supporting critical industry sponsored clinical research projects through expert grant and contract management! Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $59,829.00 to USD $96,900.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. 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Alabama + 32 moreAll locations: Alabama | Arizona | California | Colorado | Connecticut | Delaware | Florida | Georgia | Hawaii | Illinois | Indiana | Iowa | Kentucky | Louisiana | Maine | Maryland | Massachusetts | Michigan | Missouri | Montana | New Hampshire | New Jersey | New York | North Carolina | Ohio | Oregon | Pennsylvania | South Carolina | Tennessee | Texas | Virginia | Washington | District Of Columbia
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Oncology Nurse Coordinator

University of Utah

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Vanderbilt University Medical Center logo

Clinical Research Coordinator 4

Vanderbilt University Medical Center

Based in Nashville, Tennessee, Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility and a leader in medical research, education, a

Title: Clinical Research Coordinator 4 Location: Nashville United States Full time Job Description: Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research. Organization: General Pediatrics Job Summary: In your pivotal role as Clinical/Translational Research Coordinator IV, you will lead day-to-day operations of the multi-site DOSE Trial with minimal supervision, ensuring high-quality study conduct, regulatory compliance, and effective coordination across participating sites. You will make advanced independent decisions, demonstrate strong organizational skills, and supervise and support research staff to ensure excellent study implementation. REQUIRED: - Bachelor's Degree (or equivalent experience) - 5 years of relevant research experience - Previous IRB experience - Ability to effectively lead a team while fostering collaboration and working alongside team members You will work Monday through Friday during traditional daytime business hours, with flexibility being essential. This role follows a hybrid remote schedule, and when on-site, you will be based at Vanderbilt Children's Hospital. . DEPARTMENT SUMMARY: The Department of Pediatrics at VUMC is one of the largest departments within the medical center and we are proud to be home to some 460 primary faculty, 270 community-based volunteer faculty, 82 clinical fellows, 127 residents, and over 300 administrative and research staff. The Department is rooted in a rich history of commitment to excellence in research, education, and patient care. Our faculty, clinicians, fellows, and trainees represent the very best of academic medicine - extraordinary people doing incredible things to advance the care for children in Middle Tennessee, across the nation, and throughout the world. The result is a Department which reaches far beyond the walls of our hospital to provide high-quality patient care, to train the next generation of leaders in pediatric medicine, and to advance our knowledge of important conditions that affect vulnerable infants and children through world class research. For more information, please visit https://pediatrics.vumc.org/message-chair. KEY RESPONSIBILITIES - Lead daily study operations; coordinate activities across multiple clinical sites - Serve as the central communication point between investigators, site teams, and collaborators - Facilitate steering committee and investigator meetings - Troubleshoot site challenges and ensure milestone completion. - Prepare and oversee IRB submissions, amendments, continuing reviews, and adverse event reporting - Maintain protocol adherence across all sites - Update manuals of operations and ensure compliance with institutional and federal regulations. - Oversee REDCap database development and maintenance Train staff in data entry procedures - Conduct routine data quality checks - Coordinate with biostatistics teams - Supervise research assistants, coordinators, and interns - Conduct onboarding, training, and performance feedback - Promote a collaborative team culture - Ensure strong staff performance across all study tasks - Oversee recruitment and consent workflows - Maintain relationships with participating families and community partners - Support culturally responsive communication (Spanish language skills preferred). - Assist with progress reports, manuscripts, abstracts, and grant‑related materials - Contribute to cross‑project collaborations within the research group. 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Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project repositories. • Study Design & Conduct (Advanced): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study. • Clinical Research (Advanced): Knows what job-related resources are available throughout the company. Prepares final reports and manuscripts for publication. Coordinates with an ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects. Can quickly sort through volumes of information to get the right answer. Has a working knowledge of most of the department's information resources. Is a respected clinical research analyst within the company. • People Management (Intermediate): Successfully resolves conflicts and disciplinary problems. Provides counseling and career development planning to subordinates. Constructively gives timely positive and negative feedback, confronting individual performance problems in a professional and sensitive manner. Aware of the values, abilities and needs of others. Demonstrates the ability to create a positive work climate, establishing a feeling of partnership and empowering others. Has set, coached and assessed the assignment objectives of subordinates. Practices and rewards behaviors supportive of company values. Our Academic Enterprise is one of the nation's longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease. Aligning with Vanderbilt Health's Strategic Directions, the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff. Core Accountabilities: Organizational Impact: Delivers projects/assignments that have a direct impact on goals/objectives of the unit/department that the job is in. Problem Solving/ Complexity of work: Conducts extensive analysis of situations or data to resolve numerous, complex issues; may involve the input/work of others. Breadth of Knowledge: Has in-depth level of knowledge within a professional area and working knowledge of other areas. Team Interaction: May lead mid-sized projects; coaches and guides team members. Core Capabilities : Supporting Colleagues: - Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas. - Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships. - Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. 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Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure. - Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area. - Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation: - Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches. - Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges. - Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements. Position Qualifications: Responsibilities: Certifications : Certified Clinical Research Coordinator - Certification - Others, Certified Clinical Research Professional - Society of Clinical Research Associates (SOCRA), LIC-Licensed Discipline Specific - Licensure-Others Work Experience : Relevant Work Experience Experience Level : 5 years Education : Bachelor's Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.

Tennessee
Job Closed
Full TimeHybridTeam 501-1,000Since 1868H1B No Sponsor

Title: Clinical Research Coordinator Location: Boston United States Hybrid Research Job Description: Overview Tufts University School of Medicine- Department of Molecular Biology and Microbiology's mission is to improve global health by using molecular genetics and innovation to address fundamental and medically related problems in microbiology. Training is a core tenet of our approach, and our students, postdocs, and staff are key drivers of our scientific impact. We are committed to fostering a diverse scientific community and aim to improve our core values by promoting inclusivity, diversity, and antiracism. Our department was founded with community building, mentorship, and collaboration as central values, and we continue to prioritize this culture in our department. We believe that fostering an environment that welcomes a diversity of perspectives will lead to more innovative and impactful science. What You'll Do Under the supervision of the Clinical Research Manager and Principal Investigator, this position supports the day-to-day execution of an observational clinical research study focused on Lyme disease. The coordinator will focus on participant recruitment and screening, consent support, in-person and remote study visits, and specimen logistics and coordination. Principal Duties & Responsibilities: Participant Recruitment & Screening - Screen and pre-screen potential participants for eligibility using protocol-defined criteria. Coordinate with study physicians and clinical partners to confirm eligibility. Support informed consent discussions and documentation during enrollment visits Study Visits & Data Collection - Conduct in-person (on-site or home visit) and remote study visits, including administration of study questionnaires and support of sample collection activities. Perform chart abstraction and source document review. Conduct visit reminders and follow-up communications with participants. Support remote data collection sites with sample collection and troubleshooting basic technical issues related to iPads. Ensure all visit activities are completed in accordance with protocol requirement Specimen & Supply Logistics - Prepare, assemble, distribute, and replenish specimen collection kits and study supplies across data collection sites. Travel to the central laboratory to obtain specimen kits and supplies as needed. Transport collected specimens to laboratories in accordance with protocol and biosafety requirements. Maintain inventory of study materials and supplies. Specimen Shipping, Courier & Mobile Phlebotomy Coordination - Coordinate FedEx shipments, courier pickups, and mobile phlebotomy visits, including scheduling, tracking, and troubleshooting. Ensure proper specimen packaging, labeling, documentation, and shipping supply availability. Communicate shipment or collection issues promptly to the Clinical Research Manager. Site & Staff Support - Assist remote data collection sites with visit preparation and protocol adherence. Provide reminders to remote staff regarding required visit procedures and materials. Troubleshoot basic technical issues with iPads and electronic data collection tools Communicate issues, deviations, or concerns promptly to the Clinical Research Manager Compliance & Confidentiality. Maintain participant confidentiality in accordance with HIPAA regulations. Follow institutional policies, study protocols, and standard operating procedures. Escalate protocol compliance concerns to the Clinical Research Manager - Participant recruitment, screening, consent support - Study visits (in-person, home, remote) - Retention activities & visit reminders - Specimen logistics & shipping (kits, FedEx, courier, lab runs) - Specimen collection coordination & scheduling - Data review - Site support/troubleshooting - General administrative coordination/documentation What We're Looking For Basic Requirements: Knowledge and experience typically acquired by: - Bachelor's Degree or four years of related experience - 1+ years experience as a Clinical Research Study Coordinator or equivalent position - Valid driver's license, access to a vehicle, and willingness to travel to homes, clinics, and labs - Comfort with participant-facing research activities - Familiarity with electronic data capture systems (e.g. REDCap or similar) Preferred Qualifications: - Prior experience and comfort using REDCap - Experience consenting participants, administering research questionnaires, and conducting participant visits for clinical research studies - Proficiency in Spanish, Portuguese, or Haitian Creole - Familiarity with tablet-based data collection tools (e.g., iPads) - Experience using EPIC (electronic health record) for participant identification, chart review, and clinical research-related communication (e.g., MyChart) Pay Range Minimum $22.50, Midpoint $26.80, Maximum $31.10 Salary is based on related experience, expertise, and internal equity; generally, new hires can expect pay between the minimum and midpoint of the range. Responsibilities Under the supervision of the Clinical Research Manager and Principal Investigator, this position supports the day-to-day execution of an observational clinical research study focused on Lyme disease. The coordinator will focus on participant recruitment and screening, consent support, in-person and remote study visits, and specimen logistics and coordination. Principal Duties & Responsibilities: Participant Recruitment & Screening - Screen and pre-screen potential participants for eligibility using protocol-defined criteria. Coordinate with study physicians and clinical partners to confirm eligibility. Support informed consent discussions and documentation during enrollment visits Study Visits & Data Collection - Conduct in-person (on-site or home visit) and remote study visits, including administration of study questionnaires and support of sample collection activities. Perform chart abstraction and source document review. Conduct visit reminders and follow-up communications with participants. Support remote data collection sites with sample collection and troubleshooting basic technical issues related to iPads. Ensure all visit activities are completed in accordance with protocol requirement Specimen & Supply Logistics - Prepare, assemble, distribute, and replenish specimen collection kits and study supplies across data collection sites. Travel to the central laboratory to obtain specimen kits and supplies as needed. Transport collected specimens to laboratories in accordance with protocol and biosafety requirements. Maintain inventory of study materials and supplies. Specimen Shipping, Courier & Mobile Phlebotomy Coordination - Coordinate FedEx shipments, courier pickups, and mobile phlebotomy visits, including scheduling, tracking, and troubleshooting. Ensure proper specimen packaging, labeling, documentation, and shipping supply availability. Communicate shipment or collection issues promptly to the Clinical Research Manager. Site & Staff Support - Assist remote data collection sites with visit preparation and protocol adherence. Provide reminders to remote staff regarding required visit procedures and materials. Troubleshoot basic technical issues with iPads and electronic data collection tools Communicate issues, deviations, or concerns promptly to the Clinical Research Manager Compliance & Confidentiality. Maintain participant confidentiality in accordance with HIPAA regulations. Follow institutional policies, study protocols, and standard operating procedures. Escalate protocol compliance concerns to the Clinical Research Manager - Participant recruitment, screening, consent support - Study visits (in-person, home, remote) - Retention activities & visit reminders - Specimen logistics & shipping (kits, FedEx, courier, lab runs) - Specimen collection coordination & scheduling - Data review - Site support/troubleshooting - General administrative coordination/documentation Qualifications Basic Requirements: Knowledge and experience typically acquired by: - Bachelor's Degree or four years of related experience - 1+ years experience as a Clinical Research Study Coordinator or equivalent position - Valid driver's license, access to a vehicle, and willingness to travel to homes, clinics, and labs - Comfort with participant-facing research activities - Familiarity with electronic data capture systems (e.g. REDCap or similar) Preferred Qualifications: - Prior experience and comfort using REDCap - Experience consenting participants, administering research questionnaires, and conducting participant visits for clinical research studies - Proficiency in Spanish, Portuguese, or Haitian Creole - Familiarity with tablet-based data collection tools (e.g., iPads) - Experience using EPIC (electronic health record) for participant identification, chart review, and clinical research-related communication (e.g., MyChart)

Massachusetts
$22 - $31 / hour