Clinical Trial Manager
New
T
TransPerfectClinical research
US-based and remote. There is 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 at least 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 experience.
- At least 5 years of clinical research experience.
- At least 2 years coordinating studies at a clinical research site.
- At least 1 year supervising or leading research staff; equivalent informal leadership experience is acceptable.
- Working knowledge of GCP, ICH guidelines, FDA regulations (21 CFR Parts 50, 54, 56, and 312/812), and HIPAA.
- Experience with IRB submissions, informed consent processes, and regulatory documentation.
- Strong organizational skills and ability to manage multiple studies, deadlines, and priorities.
- Excellent written and verbal communication skills with sponsors, monitors, patients, and clinical staff.
- Proficiency with Microsoft Office and comfort learning EDC, CTMS, eRegulatory, and EHR systems.
- Ability to travel to Midwest clinical sites, especially during study startup.
- Current ACRP (CCRC, CCRP) or SOCRA (CCRP) certification is preferred.
- Experience with study budgeting, contract review, sponsor negotiations, clinical research billing compliance, Medicare coverage analysis, FDA inspections, or sponsor audits is preferred.
Responsibilities
- Assess study feasibility, complete sponsor and CRO questionnaires, and participate in pre-study and site qualification visits.
- Prepare and submit IRB applications, informed consent forms, amendments, continuing reviews, and safety reports.
- Coordinate clinical trial and confidentiality agreements, study budgets, and site initiation and activation.
- Oversee study conduct, participant recruitment and enrollment, consent, scheduling, and retention.
- Ensure source documentation and EDC data entry are accurate and timely, and oversee query resolution and safety reporting.
- Oversee investigational product accountability and specimen collection, processing, storage, and shipment.
- Serve as the primary contact for sponsors, CROs, and monitors; host monitoring visits and resolve findings.
- Maintain regulatory files, research SOPs, staff training records, and readiness for audits and inspections; track corrective and preventive actions.
- Track study budgets, invoicing, sponsor payments, research billing, supplies, equipment records, and study reports.
- Hire, train, schedule, supervise, and evaluate research staff, and allocate workload across studies.
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