Clinical Trial Manager - Contract to Hire

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.