Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed. What You’ll Do: • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s). • Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads. • Provides system support (i.e., Activate & eTMF) and ensures system databases are always current. • Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. • Assists with study-specific translation materials and translation QC upon request. • Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. • Where applicable, conducts on-site feasibility visits (Asia Pac only). • May support scheduling of client and/or internal meetings. • May review and track of local regulatory documents. • May provide system support (i.e., Activate & eTMF). May support RBM activities. • May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s). • Transmits documents to client and centralized IRB/IEC. • Maintains vendor trackers. • Supports start-up team in Regulatory submissions. • Works directly with sites to obtain documents related to site selection. • Assists the project team with the preparation of regulatory compliance review packages. • Provides support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned. • May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. • Documents in real time all communication, attempts an follow up associated with site contact and survey responses. • Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked. • Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks. • Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalate concerns/non-compliance to management. • May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harness this knowledge base when performing local tiering of sites. • Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information. • Contributes to the development and roll-out of global strategic feasibility processes and best practices. • Trains new personnel in processes and systems. • Utilizes local knowledge to contribute to the identification and development of new sites. Education and Experience Requirements: • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. • Bachelor's degree preferred. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Good English language and grammar skills and proficient local language skills as needed • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete the organizations clinical training program • Self-motivated, positive attitude and good interpersonal skills • Effective oral and written communication skills • Good interpersonal skills • Essential judgment and decision-making skills • Capable of accurately following project work instructions • Good negotiation skills • Independent thinker • Ability to manage risk and perform risk escalation appropriately Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment. • Occasional drives to site locations. Potential Occasional travel required.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Documentation Specialist enhances the overall quality and accuracy of clinical documentation on a concurrent and retrospective basis through daily review and interactions with physicians and healthcare providers. They utilize clinical and coding expertise to analyze documentation, ensuring it accurately reflects the level of service provided. This role supports timely and precise capture of quality metrics to improve patient care, physician documentation, and hospital outcomes. - Perform daily review of clinical documentation and interact with physicians and providers to ensure completeness and accuracy. - Analyze and evaluate documentation to ensure it reflects appropriate levels of care and supports quality measures. - Support timely coding and documentation processes to optimize hospital and physician performance metrics. - Collaborate with clinical teams to identify documentation gaps and implement improvement strategies. - Stay current with coding guidelines, documentation standards, and quality measurement requirements. - Maintain compliance with regulatory and accreditation standards related to clinical documentation. - Support education and training initiatives for staff regarding documentation best practices. - Utilize clinical and coding expertise to support continuous quality improvement initiatives. Qualifications - Associate’s Degree required; Bachelor's Degree preferred. - 0-3 years of relevant experience in clinical documentation, coding, or related fields. - Active Registered Nurse (RN) license in Indiana or Nurse Licensure Compact (NLC) RN license, or RHIA/RHIT and/or CCS certification. - If RN licensed, 3-5 years of strong, varied clinical experience in an acute care setting preferred. - CCDS and/or CDIP credential preferred; obtain within 4 years of hire. - Ability to work independently and produce high-quality outcomes. - Working knowledge of computers and software applications such as Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, SharePoint, Teams) and Cerner EMR. - Ability to sit for extended periods. - Position is remote but may require occasional on-site meetings with advanced notice. Benefits - Comprehensive benefits package including health, dental, and vision insurance - Retirement savings plan with employer match - Tuition reimbursement and professional development opportunities - Employee assistance programs and wellness initiatives - Supportive work environment committed to safety and excellence

About Blackbird Health Blackbird Health is clinician-founded, owned, and operated by dedicated professionals. We believe that providing the best care for children starts with building the best possible team. We deliver virtual and in-person mental health services across Pennsylvania, Virginia, and New Jersey—and we’re growing into new markets in 2026. At Blackbird, we take a whole-child approach, looking at how the brain, body, and behavior interact to address the root causes of challenges, not just the symptoms. Every role matters here, and you’ll join a collaborative, supportive, and innovative team that’s shaping the future of pediatric mental health care. If you’re passionate about helping children and families while growing your career, Blackbird is the place to make an impact. Join us and help change mental health care for children for the better! Join our Talent Network! Interested in joining Blackbird Health but don’t see the perfect role listed right now? We’d still love to connect. Submit your information to join our Talent Network and be considered for future opportunities. We're continuously growing our team of clinicians. We are hiring for W2 and 1099 clinicians, both provisionally and fully licensed across multiple locations in Pennsylvania, Virginia, Maryland and New Jersey. What We're Looking For: We hire Social Workers (LSW, LCSW, SiSW, LMSW), Licensed Professional Counselors (LPC), Licensed Marriage and Family Therapists (LMFT), and other mental health clinicians with experience working with children and adolescents. Opportunities include: - W2 full-time and part-time positions - 1099 contract roles - Virtual and in-person locations across PA, VA, MD, and NJ Why Blackbird? - Guaranteed caseload from day one - Flexible scheduling - Full credentialing support - Weekly paid clinical consultations - Competitive compensation and benefits - Career growth opportunities The Blackbird Talent Network Submit your application below and our team will be in touch. By applying, you agree to receive communications from Blackbird about current and future opportunities that may align with your experience. Join us! To raise the standard of pediatric mental health care through accurate understanding and precise treatment that reflect how each child’s brain, body, and behavior work together. “It's so rare to find comprehensive care like this---from testing to therapy to med management (and more)--all in one place. In addition, the school advocacy support we receive is unprecedented. We no longer feel like we are managing things alone.” Fostering an inclusive environment: Blackbird is committed to cultivating and preserving a culture of inclusion and belonging. We are able to grow and learn better together with a diverse team of employees. In recruiting for our team, we welcome the unique contributions that you can bring in terms of your education, opinions, culture, ethnicity, race, sex, gender identity and expression, nation of origin, age, languages spoken, veteran status, color, religion, disability, sexual orientation and beliefs. Blackbird provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type. If you need a reasonable accommodation during the application or interview process, please contact us at recruiting@blackbirdhealth.com so we can support you. Our patient support team is busy helping children and families, please do not call or email them about your application — this helps us process your application more efficiently.

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Position Summary: The Clinical Research Associate/Clinical Research Monitor (CRA) plays a key role in the quality oversight and regulatory integrity of a large, high-profile, multi-center NIH-funded stroke outcomes study enrolling and following 8,000 participants across 20 U.S. sites. The CRA is responsible not only for conducting risk-based monitoring activities in accordance with ICH-GCP guidelines, federal regulations, study SOPs and the approved monitoring plan, but also for contributing to the ongoing refinement of the study’s quality oversight strategy. This includes proactively evaluating site performance trends, identifying emerging risks, and recommending monitoring and quality control adaptations aligned with the study’s lifecycle (startup, peak recruitment, retention-focused follow-up, and close-out). This role requires advanced clinical research expertise, strong regulatory knowledge, independent judgment, and the ability to partner closely with study leadership to ensure participant safety, data integrity, and operational excellence across a complex, multi-site network. Qualifications Competencies Required: - Excellent oral and written communication skills - Strong interpersonal and relationship-building skills with investigators and site staff - Ability to work independently with a high degree of accountability - Ability to travel up to 10% of the time for meetings and on-site monitoring visits - Ability to identify operational, regulatory, or quality risks and develop strategic, solution-oriented recommendations - Exceptional attention to detail and strong organizational skills - Proficiency navigating and utilizing multiple online systems and software platforms - Advanced knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections - Ability to analyze performance metrics and develop and implement risk-based quality management strategies Primary Duties: - Conduct site monitoring visits (including Site Qualification Visits, Site Initiation Visits, Monitoring Visits, and Close-Out Visits) in accordance with the approved monitoring plan. - Exercise partial ownership of the study’s quality oversight framework by evaluating the effectiveness of the existing monitoring plan and recommending strategic revisions based on study phase, enrollment status, retention priorities, protocol amendments, monitoring findings, and site performance trends. - Collaborate with study leadership to implement adaptive monitoring approaches, including modifications to visit frequency, scope of review, central versus on-site monitoring balance, and targeted risk mitigation strategies. - Assess site compliance with the study protocol, informed consent requirements, IRB approvals, and regulatory obligations, ensuring protection of participant rights and safety. - Perform source data verification and source document review to ensure that data entered into electronic case report forms (eCRFs) are accurate, complete, and verifiable from source documentation. - Identify systemic data quality trends or recurring compliance issues and provide recommendations for corrective and preventive actions (CAPA) at both the site and study-wide levels. - Review and assess essential regulatory documents, including IRB documentation, delegation logs, training logs, and protocol deviation logs - Ensure timely resolution of data queries and protocol deviations in collaboration with site personnel and the Coordinating Center. - Provide study-specific training to investigators and site staff throughout the study lifecycle, reinforcing protocol adherence and regulatory best practices. - Maintain regular communication with sites to support enrollment, data quality, retention efforts, and adherence to study procedures. - Document monitoring activities, findings, and follow-up actions through detailed monitoring reports and formal correspondence within established timelines. - Report significant findings, trends, or compliance concerns to study leadership and contribute to action planning discussions. - Participate in weekly study team meetings and actively contribute to discussions regarding site performance metrics, quality indicators, and strategic oversight planning. Other Tasks, as required: - Participate in site and/or investigator selection processes, providing input regarding site readiness and risk profile. - Contribute to the development and refinement of monitoring tools, risk assessment frameworks, tracking systems, and quality improvement initiatives. - Perform central monitoring activities, including analysis of recruitment trends, retention metrics, protocol deviation patterns, and data quality dashboards. - Support preparation for sponsor reviews or regulatory inspections, including documentation review and corrective action planning. - Attend and participate in investigator meetings, coordinator meetings, and study training sessions as needed. - Submit monitoring visit expense reports and administrative documentation in a timely manner. Education - BA or BS required. Clinical research professional certification preferred (e.g., ACRP, SOCRA). Experience - Minimum of 2 years of experience in clinical research; 3–5 years preferred with a minimum of 1 year of monitoring experience. - Experience in multi-center clinical trials and/or stroke, neurology, or outcomes research preferred. - Demonstrated knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections. - Experience contributing to risk-based monitoring strategies or quality oversight initiatives preferred. - Proficiency with Microsoft Office applications and clinical research data management systems. - Demonstrated ability to manage monitoring responsibilities across multiple sites. Knowledge, Skills and Abilities - Ability to work independently and as a team member. - Strong attention to detail and organizational skills. - Knowledge of clinical research protocols. - Knowledge of data management programs. - Computer literacy. - Knowledge of clinical trials, research, and general medicine. Additional Job Details (if applicable) Physical Requirements - Standing Frequently (34-66%) - Walking Frequently (34-66%) - Sitting Occasionally (3-33%) - Lifting Frequently (34-66%) 35lbs+ (w/assisted device) - Carrying Frequently (34-66%) 20lbs - 35lbs - Pushing Occasionally (3-33%) - Pulling Occasionally (3-33%) - Climbing Rarely (Less than 2%) - Balancing Frequently (34-66%) - Stooping Occasionally (3-33%) - Kneeling Occasionally (3-33%) - Crouching Occasionally (3-33%) - Crawling Rarely (Less than 2%) - Reaching Frequently (34-66%) - Gross Manipulation (Handling) Frequently (34-66%) - Fine Manipulation (Fingering) Frequently (34-66%) - Feeling Constantly (67-100%) - Foot Use Rarely (Less than 2%) - Vision - Far Constantly (67-100%) - Vision - Near Constantly (67-100%) - Talking Constantly (67-100%) - Hearing Constantly (67-100%) Remote Type Remote Work Location 175 Cambridge Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $50,502.40 - $82,014.40/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.