About the role
TransPerfect is sourcing this role on behalf of our client, a contract research organization (CRO). Candidates will apply through TransPerfect.
Position Overview
Type: Full-time, 12-month contract-to-hire
Location: US-based and remote. There is no specific home location requirement.
Travel: Periodic site visits. Candidates must be able to visit Midwest clinical sites, especially during study startup, so travel flexibility is required.
Openings: One Clinical Trial Manager (CTM) for two studies expected to begin in early January.
Key Responsibilities
Study Start-Up and Feasibility
Evaluate new studies with the Principal Investigator (PI). Assess protocol feasibility, patient population, staffing, equipment, and space.
Complete Sponsor and CRO feasibility questionnaires. Take part in pre-study and site qualification visits.
Prepare and submit IRB applications, informed consent forms, amendments, continuing reviews, and safety reports.
Coordinate review of Clinical Trial Agreements (CTAs) and Confidentiality Agreements with clinic leadership and legal counsel.
Develop and negotiate study budgets with Sponsors. This includes per-patient costs, start-up fees, and pass-through expenses.
Lead site initiation visits. Activate the site only after all approvals, training, and supplies are in place.
Study Conduct and Oversight
Oversee day-to-day conduct of all active studies. Ensure compliance with the protocol, GCP, FDA regulations, HIPAA, and clinic policies.
Oversee participant recruitment, screening, consent, enrollment, scheduling, and retention. Develop recruitment strategies suited to the clinic's patient population.
Verify that informed consent is properly obtained and documented before any study procedures.
Ensure source documentation and EDC data entry are accurate and timely. Oversee query resolution.
Ensure adverse events, serious adverse events, and protocol deviations are documented and reported to the PI, Sponsor, and IRB on time.
Oversee investigational product accountability: receipt, storage, dispensing, temperature monitoring, and return or destruction.
Oversee specimen collection, processing, storage, and shipment per lab manuals, including staff shipping training.
Act as primary contact for Sponsors, CROs, and monitors. Host monitoring visits and resolve findings promptly.
Regulatory and Quality
Maintain inspection-ready regulatory binders and electronic files for each study. These include Form FDA 1572s, delegation logs, financial disclosures, CVs, licenses, and training records.
Ensure all research staff hold current GCP, human subjects protection, and protocol-specific training. Ensure the PI delegates responsibilities appropriately.
Maintain and update clinic research SOPs, templates, and work instructions.
Prepare the clinic for Sponsor audits and FDA or other regulatory inspections. Lead development and tracking of corrective and preventive actions (CAPAs).
Ensure applicable studies are registered and updated on ClinicalTrials.gov, as directed.
Financial and Administrative Management
Track study budgets, invoiceable items, and Sponsor payments. Ensure timely invoicing and reconciliation.
Support research billing compliance by separating routine-care charges from research-related charges, in coordination with billing staff.
Prepare enrollment, financial, and performance reports for the PI and clinic leadership.
Manage study supplies, equipment calibration and maintenance records, and vendor relationships.
Team Leadership
Hire, train, schedule, supervise, and evaluate Clinical Research Coordinators and other research staff.
Allocate workload across studies. Monitor staff capacity before new trials are accepted.
Foster collaboration between research staff and clinical staff (physicians, nurses, medical assistants, front desk, and billing).
Identify and recommend practical improvements to research processes, recruitment, and efficiency.
Perform other duties as needed to support the clinic's research program.
Minimum Qualifications
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, including at least 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 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. Ability to manage multiple studies, deadlines, and priorities at once.
Excellent written and verbal communication skills with Sponsors, monitors, patients, and clinical staff.
Proficiency with Microsoft Office. Comfort learning EDC, CTMS, eRegulatory, and EHR systems.
Preferred Qualifications
Current ACRP (CCRC, CCRP) or SOCRA (CCRP) certification.
Experience with study budgeting, contract review, and Sponsor negotiations.
Experience with clinical research billing compliance and Medicare coverage analysis.
Experience in the clinic's therapeutic areas. Rare disease or pediatric studies are a plus.
Clinical skills such as phlebotomy, vital signs, or ECG, as permitted by licensure and scope of practice.
Experience with FDA inspections or Sponsor audits.
About TransPerfect: TransPerfect is a global leader in language and technology solutions. It is sourcing this role on behalf of its client. Interested candidates should apply through TransPerfect.
Originally posted on Himalayas
