The posting
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.
