Senior Clinical Research Associate / Associate Clinical Trial Manager
New
J
JobgetherClinical research
Remote work arrangement within the United States., Study teams, CROs, vendors, investigators, and clinical sites across multiple time zones.Full-TimeSenior
Salary110,000 - 120,000 USD per year
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Job Details
- Experience
- At least 4 years of clinical research experience in a biotechnology, pharmaceutical, or CRO environment, including CRA and clinical site monitoring experience.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field, or equivalent relevant experience.
- At least 4 years of clinical research experience in a biotechnology, pharmaceutical, or CRO environment.
- CRA and clinical site monitoring experience.
- Experience supporting clinical trials through study start-up, conduct, and closeout; sponsor-side experience is preferred.
- Working knowledge of ICH-GCP, applicable clinical research regulations, and the clinical trial process.
- Experience working with clinical sites, CROs, and external study vendors.
- Familiarity with EDC, CTMS, eTMF, IRT, and eCOA systems.
- Strong organizational and project coordination skills, with the ability to manage multiple priorities and study deliverables.
- Ability to work independently in a remote environment and communicate effectively with study teams, CROs, vendors, investigators, and clinical sites across multiple time zones.
- Availability to participate regularly in virtual study-team, CRO/vendor, and site meetings.
- Willingness to travel approximately 10–20% for sponsor oversight visits, investigator meetings, critical site visits, internal meetings, and other study-related activities.
Responsibilities
- Support day-to-day clinical study activities from start-up and enrollment through study conduct, database lock, and closeout.
- Develop, maintain, and track study timelines, milestones, risks, issues, and action items.
- Coordinate internal functions, CROs, vendors, and clinical sites, escalating operational risks and recommending mitigations.
- Provide sponsor oversight of CROs and vendors, monitoring performance against timelines, quality expectations, contracts, and deliverables.
- Assist with vendor budgets, change orders, invoices, forecasts, financial tracking, study team meetings, and operational metrics.
- Support site feasibility, activation, monitoring follow-up, and issue resolution; review monitoring reports, findings, and protocol deviations.
- Coordinate investigational product distribution and accountability, study supplies, biological sample logistics, and laboratory sample tracking.
- Contribute to clinical study documents, plans, tools, site-facing materials, and operational workflows.
- Support clinical data review and cleaning, use of clinical trial systems, regulatory submissions, TMF completeness, inspection readiness, audits, and CAPAs.
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