Clinical Trial Manager
New
J
JobgetherClinical research
Fully remote working arrangement within the United States, with no specific home location requirement.ContractManager
Salary not disclosed
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Job Details
- Experience
- At least 5 years of clinical research experience, including a minimum of 2 years coordinating studies at a clinical research site. At least 1 year of experience supervising or leading research staff.
- Required Skills
- Microsoft OfficeHIPAA
Requirements
- Bachelor's degree in life sciences, nursing, healthcare, or a related field, or an equivalent combination of education and relevant professional experience.
- At least 5 years of clinical research experience, including a minimum of 2 years coordinating studies at a clinical research site.
- At least 1 year of experience supervising or leading research staff; equivalent informal leadership experience is considered.
- Working knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA regulations (21 CFR Parts 50, 54, 56, and 312/812), and HIPAA.
- Experience preparing IRB submissions, managing informed consent processes, and maintaining regulatory documentation.
- Strong organizational and project management skills for overseeing multiple studies, deadlines, and priorities.
- Written and verbal communication skills for interacting with Sponsors, clinical monitors, patients, and healthcare professionals.
- Proficiency in Microsoft Office and ability to learn and use EDC, Clinical Trial Management Systems (CTMS), eRegulatory, and Electronic Health Record (EHR) platforms.
- Preferred: Current ACRP certification (CCRC or CCRP) or SOCRA certification (CCRP).
- Preferred: Experience with clinical study budgeting, contract reviews, Sponsor negotiations, billing compliance, or Medicare coverage analysis.
Responsibilities
- Evaluate study feasibility with Principal Investigators and complete Sponsor and CRO feasibility questionnaires.
- Prepare and submit IRB applications, informed consent forms, amendments, continuing reviews, and safety reports.
- Coordinate study agreements and budgets, and lead site initiation visits.
- Oversee study execution, participant recruitment, screening, enrollment, scheduling, and retention.
- Monitor source documentation, EDC entries, and query resolution to maintain accurate study data.
- Ensure adverse events, serious adverse events, and protocol deviations are documented and reported on time.
- Maintain regulatory files, staff training records, SOPs, and inspection readiness; coordinate audits and inspections.
- Monitor study budgets, invoicing, financial reconciliation, supplies, equipment records, and vendor relationships.
- Recruit, train, schedule, supervise, and evaluate research personnel; allocate workloads across studies.
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