Clinical Trial Manager - Contract to Hire

TransPerfect•New York, NY

3d•Remote

About The Position

TransPerfect is sourcing a Clinical Trial Manager on behalf of its client, a contract research organization (CRO). This is a full-time, 12-month contract-to-hire role for a US-based remote worker, with periodic site visits. The position will manage two studies expected to begin in early January. The manager must be able to travel to Midwest clinical sites, particularly during study startup. The Clinical Trial Manager oversees study feasibility and startup, including PI evaluation, site qualification, IRB submissions, agreement and budget coordination, and site activation. The role manages daily study conduct and compliance, participant recruitment and care, data quality, safety reporting, investigational product and specimen handling, and Sponsor and CRO communications. The position also maintains regulatory and quality systems, supports audits and inspections, tracks study finances and reporting, and supervises research staff. It works closely with clinic leadership and clinical, billing, and research personnel to manage studies and improve the clinic’s research program.

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, 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 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.
Comfort learning EDC, CTMS, eRegulatory, and EHR systems.
Ability to travel periodically to Midwest clinical sites, especially during study startup.

Nice To Haves

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 study experience.
Clinical skills such as phlebotomy, vital signs, or ECG, as permitted by licensure and scope of practice.
Experience with FDA inspections or Sponsor audits.

Responsibilities

Evaluate new studies with the Principal Investigator and assess protocol feasibility, patient population, staffing, equipment, and space.
Complete Sponsor and CRO feasibility 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 Agreement and Confidentiality Agreement reviews with clinic leadership and legal counsel.
Develop and negotiate study budgets with Sponsors, including per-patient costs, start-up fees, and pass-through expenses.
Lead site initiation visits and activate sites after required approvals, training, and supplies are in place.
Oversee day-to-day conduct of active studies and compliance with protocols, GCP, FDA regulations, HIPAA, and clinic policies.
Oversee participant recruitment, screening, consent, enrollment, scheduling, and retention, and develop suitable recruitment strategies.
Verify informed consent is obtained and documented before study procedures.
Ensure source documentation and EDC data entry are accurate and timely, and oversee query resolution.
Ensure adverse events, serious adverse events, and protocol deviations are documented and reported on time to the PI, Sponsor, and IRB.
Oversee investigational product receipt, storage, dispensing, temperature monitoring, and return or destruction.
Oversee specimen collection, processing, storage, and shipment according to lab manuals, including staff shipping training.
Serve as the primary contact for Sponsors, CROs, and monitors; host monitoring visits and promptly resolve findings.
Maintain inspection-ready regulatory binders and electronic study files, including required forms, logs, disclosures, credentials, and training records.
Ensure research staff maintain current GCP, human subjects protection, and protocol-specific training, and 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, and lead development and tracking of CAPAs.
Ensure applicable studies are registered and updated on ClinicalTrials.gov as directed.
Track study budgets, invoiceable items, and Sponsor payments; ensure timely invoicing and reconciliation.
Support research billing compliance by separating routine-care and 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.
Hire, train, schedule, supervise, and evaluate Clinical Research Coordinators and other research staff.
Allocate workload across studies and monitor staff capacity before accepting new trials.
Foster collaboration between research staff and clinical staff, including physicians, nurses, medical assistants, front desk, and billing personnel.
Identify and recommend practical improvements to research processes, recruitment, and efficiency.
Perform other duties as needed to support the clinic's research program.