Clinical Trial Manager – Contract to Hire

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with the Principal Investigator to evaluate new studies and assess the feasibility of protocols, patient populations, staffing, equipment, and space.

• Complete feasibility questionnaires from Sponsors and CROs.

• Engage in pre-study and site qualification visits.

• Prepare and submit IRB applications, informed consent forms, amendments, continuing reviews, and safety reports.

• Coordinate the review of Clinical Trial Agreements and Confidentiality Agreements.

• Develop and negotiate study budgets in collaboration with Sponsors.

• Lead site initiation visits and activate sites after obtaining approvals, training, and securing necessary supplies.

• Oversee the daily conduct of active studies to ensure compliance with protocols, GCP, FDA regulations, HIPAA, and clinic policies.

• Manage participant recruitment, screening, consent, enrollment, scheduling, and retention processes.

• Ensure the accuracy and timeliness of source documentation and EDC data entry; oversee the resolution of queries.

• Document and report adverse events, serious adverse events, and protocol deviations promptly.

• Supervise investigational product accountability and the collection, processing, storage, and shipment of specimens.

• Serve as the primary contact for Sponsors, CROs, and monitors; facilitate monitoring visits and address any findings.

• Maintain inspection-ready regulatory binders and electronic files.

• Ensure that research staff receive ongoing training and that the PI appropriately delegates responsibilities.

• Update and maintain research SOPs, templates, and work instructions.

• Prepare for Sponsor audits and FDA or other regulatory inspections.

• Lead the development and tracking of corrective and preventive actions.

• Ensure that applicable studies are registered and kept current on ClinicalTrials.gov.

• Monitor study budgets, invoiceable items, Sponsor payments, and compliance with research billing.

• Prepare enrollment, financial, and performance reports for the PI and clinic leadership.

• Manage study supplies, equipment records, and vendor relationships.

• Hire, train, schedule, supervise, and evaluate Clinical Research Coordinators and other research personnel.

• Distribute workload across studies and monitor staff capacity.

• Encourage collaboration between research staff and clinical staff.

• Suggest improvements to research processes, recruitment strategies, and overall efficiency.

• Perform additional duties that support 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.

• A minimum of 5 years of clinical research experience, with at least 2 years in coordinating studies at a clinical research site.

• At least 1 year of experience in supervising or leading research staff; informal leadership experience is also acceptable.

• Familiarity with GCP, ICH guidelines, FDA regulations (21 CFR Parts 50, 54, 56, and 312/812), and HIPAA.

• Experience in IRB submissions, informed consent processes, and regulatory documentation.

• Strong organizational skills with the ability to manage multiple studies, deadlines, and priorities.

• Excellent written and verbal communication skills for interaction with Sponsors, monitors, patients, and clinical staff.

• Proficiency in Microsoft Office.

• Willingness to learn EDC, CTMS, eRegulatory, and EHR systems.

• Candidates must be able to travel to Midwest clinical sites, especially during study startup phases.

• Current ACRP (CCRC, CCRP) or SOCRA (CCRP) certification is preferred.

• Preferred experience in study budgeting, contract review, and Sponsor negotiations.

• Familiarity with clinical research billing compliance and Medicare coverage analysis is advantageous.

• Preferred experience in the clinic's therapeutic areas.

• Experience with rare disease or pediatric studies is a plus.

• Clinical skills such as phlebotomy, vital sign measurement, or ECG are preferred, as permitted by licensure and scope of practice.

• Preferred experience with FDA inspections or Sponsor audits.

🏝️ Benefits

• 12-month contract-to-hire arrangement.

• Remote work opportunity for US-based candidates.

• Periodic site visits instead of a fixed home location requirement.