Job Closed
This listing is no longer active.
ICON plc, or simply ICON, is a global provider of outsourced development services to companies in industries like biotechnology, medical devices, and pharmaceut
Clinical Site Associate
Location
United States
Posted
78 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Clinical Site Associate
ICON plc
Clinical Site 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 Clinical Site Associate (CSA) Open to candidates located anywhere in the USA. ICON is currently seeking a Clinical Site Associate (CSA) to join our diverse and dynamic team. We are looking for candidates with a minimum of one year of experience as a Study Coordinator in clinical research. In this role, you will play a pivotal part in supporting clinical trial operations by ensuring site compliance, maintaining accurate documentation, and supporting audit and inspection readiness. The position involves close collaboration with Clinical Research Associates and cross-functional teams to ensure efficient and high-quality trial execution. . What you will be doing Site Support & Oversight: - Manage site-level communications - Coordinate site trainings and systems access - Support site readiness activities including pre/post site visit tasks - Follow-up on action items Document Management: - Maintain Trial Master File (TMF) Your profile - Candidates must have completed a Bachelor’s degree in a relevant field, such as Life Sciences or Healthcare. - Previous experience in clinical research or a related field preferred - Strong organizational and communication skills - Ability to work independently and collaboratively in a fast-paced environment - Attention to detail and ability to prioritize tasks effectively 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
Related Guides
Related Categories
Related Job Pages
More Clinical Operations Jobs
Sagility combines industry-leading technology and transformation-driven BPM services with decades of healthcare domain expertise to help clients draw closer to their members. The company optimizes the entire member/patient experience through service offerings for clinical, case management, member engagement, provider solutions, payment integrity, claims cost containment, and analytics. Sagility has more than 25,000 employees across 5 countries. The Compliance Officer is responsible for supporting compliance activities across the account, ensuring adherence to regulatory standards, client requirements, and internal policies. This role assists in audits, certifications, risk assessments, and compliance training programs to help maintain operational integrity and client trust. The Compliance Officer may also provide guidance to Compliance Apprentices. Job title: Clinical Operations - Compliance Officer Job Description: JOB SUMMARY: The Compliance Officer is responsible for supporting compliance activities across the account, ensuring adherence to regulatory standards, client requirements, and internal policies. This role assists in audits, certifications, risk assessments, and compliance training programs to help maintain operational integrity and client trust. The Compliance Officer may also provide guidance to Compliance Apprentices. DUTIES & RESPONSIBILITIES: Compliance Oversight - Support the implementation and monitoring of compliance frameworks aligned with HIPAA, GLBA, PCI-DSS, and other applicable regulations. - Ensure consistent application of internal policies and client-specific compliance requirements within assigned business units. - Provide guidance and support to Compliance Apprentices as needed. - Prepares any ad hoc monthly reports based on Ops needs. Audit & Certification Support - Assist in preparing for internal and external audits, including: - ISO 27001 (Information Security) - ISO 9001 (Quality Management) - ISO 45001 (Occupational Health & Safety) - ISAE-SOC - PCI-DSS - Third-party and client-specific audits - Coordinate audit readiness activities, evidence collection, and documentation. - Track and help close audit findings under the direction of the Operations leadership. Compliance Readiness for Transitions and Expansions - Participate in Tollgate Reviews and Health Checks for new accounts or expansions as assigned. - Collaborate with operations, support teams, and client stakeholders to ensure compliance requirements are met prior to launch or transition. Disaster Recovery & Business Continuity (DR-BCP) - Maintain DR-BCP documentation and support testing activities. - Ensure DR-BCP plans are updated and compliant with client requirements. Training & Awareness - Coordinate and track completion of company-mandated and client-initiated compliance training programs. - Monitor training status and escalate gaps to the Associate Manager. - Conduct refresher sessions or send targeted communications to reinforce key compliance topics. Risk Management - Monitor and report internal compliance violations. - Coordinate with relevant teams for timely resolution of compliance issues. - Support risk mitigation by identifying recurring compliance gaps and suggesting preventive actions including but not limited to Shephertz findings Reporting & Communication - Prepare and maintain compliance dashboards, trackers, and reports for leadership and audit readiness. - Escalate critical compliance issues to the Operations Leadership and provide supporting documentation. - Support documentation and reporting requirements for internal reviews and external audits including corrective and preventive action plans - Monitor and manage Service Level Agreements (SLAs) for new and existing business, including "Table F" metrics and bi-annual SLA reviews Access Management - Manage system and platform access for associates; ensure timely additions, removals, and updates Continuous Improvement - Identify opportunities to enhance compliance processes and strengthen audit readiness. - Collaborate with internal teams to streamline workflows and improve documentation practices. - Stay informed on industry trends and share relevant best practices with the team. Work-at-Home Responsibilities - Comply with all Sagility general security and Work-at-Home security policies and procedures. - Adhere to all client-specific security policies and procedures to ensure the protection of customer data. - Maintain a secure home work environment and safeguard Sagility-provided assets, client systems, and data. - Promptly report any security-related incidents in accordance with established protocols. - Use the same internet connection that was tested during the setup process. If any changes are made to the internet connection or router during application or employment, notify the appropriate parties in advance and complete a retest to ensure compliance with requirements. - Immediately report any system performance issues or downtime to your manager and the designated local IT-SPOC. General Safety and Security - Safeguard the organization’s assets by adhering to the principles of the Quality Information Security Management System (QISMS). - Ensure the confidentiality, integrity, and availability of information essential to the organization’s business operations. - Maintain compliance with all applicable business, local, and international regulatory and legislative requirements COMPETENCY REQUIREMENTS: With Basic Competency Level in ff.: - Computer Literacy - Job Knowledge - Product Knowledge - Discipline Management With Moderate Competency Level in ff.: - People Management / Team Orientation - Coaching - Performance Management - Expertise / Analytical Skills - Problem Solving - Process Improvement - Presentation Skills With Expert Competency Level in ff.: - Communication Skills (Spoken & Written) - Change Management - Sense of Urgency - Passion for Excellence - Working in Teams / Interpersonal Skills - Work Organization - Drive for Results / Execution - Thriving in Change OTHER REQUIREMENTS: Reports to: - Senior Vice President or Operations Director Education and/or Experience: - Bachelor’s Degree in any field (no prior customer service experience required) - Associate Degree (2-year vocational course) or completion of at least 2 years of college with a minimum of 6 months of customer service experience - Experience in a BPO, healthcare, or regulated industry is an advantage. - Familiarity with regulatory standards such as HIPAA, PCI-DSS, ISO 27001, or similar frameworks is preferred. - Experience supporting audits, documentation, or compliance training is a plus. Work environment: - Hybrid setup, as applicable. - Onsite presence is required during critical activities, such as: - Internal or external audits - Client visits - Preparations in the days leading up to audits or client visits - Disaster Recovery & Business Continuity (DR-BCP) tests or evacuation drills - Key meetings and trainings - Work-at-Home (WAH) environment requirements: - Workstation PC is located in a dedicated, enclosed area at home - PC monitor is positioned away from doors and windows - Room is well-ventilated to prevent equipment overheating - Unauthorized entry to the room is prevented (e.g., keep the room locked when in use) - Telephone conversations are not audible from other areas of the house or outside - Workstation is clean and free from writing materials and unauthorized electronic devices - Adequate and stable internet connectivity is maintained Physical demands: - Ability to work for prolonged periods using a computer and other office equipment - Regular work during graveyard shift, but may adjust to morning or mid-shift as needed - Physically mobile to visit production floors as needed for compliance checks, audits, or escalations Work demands: - Ability to manage multiple compliance-related tasks and deadlines. - Must coordinate with internal teams, clients, and leadership to support compliance requirements and address routine inquiries. - Expected to work with general supervision, escalating complex issues or decisions to the Associate Manager or relevant leaders. - Must respond promptly to changes in client requirements, regulatory updates, or audit requests. - Ability to maintain accuracy and attention to detail, especially when preparing documentation or supporting audits. - Expected to remain professional and composed when handling urgent compliance issues or audit findings. The above statements are intended to indicate the general nature and level of work being performed by employees within this classification. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of employees assigned to this job. Employees in this job may perform other duties as assigned Location: Work@Home USAUnited States of America
Clinical Genomics Specialist - TX, CO, UT and AZ
Oxford Nanopore TechnologiesOxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.
What You’ll Do As a key member of our regional commercial team, your responsibilities will include: Strategic Planning & Execution - Collaborate with executive and regional leadership to define and implement commercial clinical strategies. - Partner with account and technical teams to drive territory growth and meet performance targets. - Report on regional performance, market trends, and execution adjustments. Customer Engagement & Market Influence - Build and maintain relationships with executive-level stakeholders and key opinion leaders (KOLs). - Lead collaboration opportunities for application development and evaluation. - Promote ONT's visibility through customer education and advocacy initiatives. Market Intelligence & Cross-functional Collaboration - Deliver real-time insights on market dynamics, customer feedback, and competitive trends. - Support internal decision-making by aligning external insights with product, marketing, and commercial strategies. - Act as the voice of the clinical market within internal teams. Thought Leadership & Education - Represent ONT as a subject-matter expert in the clinical genomics space. - Conduct seminars, workshops, and 1:1 engagements to drive technology adoption. - Share knowledge and insights with internal stakeholders to align efforts across teams. What You Bring Required Qualifications - Bachelor’s degree in Biomedical or Life Sciences. - 5+ years of commercial experience in the clinical or translational genomics field. - Proven success managing complex executive-level customer relationships. - Deep understanding of genomics technologies and clinical workflows. - Established network in human genetics, molecular pathology, oncology, and infectious disease. - Excellent communication, organizational, and time-management skills. - Ability to work independently in a matrixed sales/service environment. Preferred Qualifications - Master’s or PhD in Biomedical or Life Sciences. - MLS/ASCP certification or equivalent. - Experience with payer/reimbursement models and clinical testing workflows. - Knowledge of regulatory and clinical guidelines in genomics (e.g., oncology, rare disease). - Strategic mindset with strong negotiation and market insight skills. Why Join Us? At Oxford Nanopore Technologies, you’ll be part of a mission-driven team that’s reshaping the future of genomics. We offer: - A dynamic, innovative, and collaborative work environment - Opportunities for growth and leadership within a high-impact sector - Competitive compensation and benefits - A chance to directly influence the future of healthcare through cutting-edge science The salary for this role is between $113,000 and $200,00 USD. The salary offered will reflect the skills and experience of the candidate. Certain roles within ONT are eligible for annual bonus and stock. These awards are allocated based on individual performance. Employees based in the US have the option to choose healthcare benefits, participate in the company 401(k) plan and company match, we also offer short-term and long-term disability coverage, basic life insurance, and commuter benefits to name a few. We are proud to be an equal opportunity employer. We select and employ candidates only in accordance with their merits, qualifications, and abilities to perform the duties of the job regardless of gender, marital status, race, religion, color, age, disability, sexual orientation, military or veteran status. If you require an accommodation to complete the application or interview process, please contact human.resources@nanoporetech.com #LI-RP1 #LI-Remote Oxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.
• Plan, implement, evaluate, and complete full execution of assigned clinical trials • Provide oversight and coordination of the operational aspects of the functional areas on assigned projects • Provide management of full scope clinical trial projects including global trials from start-up through analysis phase
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks. - Serves as leader of the local study team on one or more studies - Provides back up to or assumes the responsibilities of the GSM as needed - Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans) - May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable - Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs) - Provides country level input on startup and recruitment milestones during planning - Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. - Accountable for resolution of site activation escalations to study teams including offering options for mitigation - Fully responsible and accountable for, as designated by the GSM: - Regional, country, and study level implementation of startup and site activation plans - Regional, country and study level recruitment strategy - Development of study level plans - Communication with the local team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plans - Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables - Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc. Requirements: - Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required - Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required - A scientific or technical degree is preferred #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.



