Clinical Trial Manager – Contract to Hire

This is a fully remote position, open to applicants in New York.

📋 Description

• Assess new research studies in collaboration with the Principal Investigator, evaluating protocol feasibility, patient demographics, staffing requirements, equipment needs, and available space.

• Complete feasibility questionnaires for Sponsors and CROs, and engage in pre-study and site qualification visits.

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

• Coordinate the review of Clinical Trial Agreements and Confidentiality Agreements in conjunction with clinic leadership and legal advisors.

• Develop and negotiate study budgets in partnership with Sponsors.

• Lead site initiation visits and activate sites post-approvals, training, and supply completion.

• Supervise the daily operations of ongoing studies, ensuring adherence to protocols, GCP, FDA regulations, HIPAA, and clinic policies.

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

• Ensure precise and timely source documentation and EDC data entry; oversee resolution of queries.

• Confirm that adverse events, serious adverse events, and protocol deviations are documented and reported punctually.

• Oversee investigational product accountability, including receipt, storage, dispensing, temperature monitoring, and proper return or destruction.

• Manage specimen collection, processing, storage, and shipment, including training staff on shipping protocols.

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

• Maintain regulatory binders and electronic study files that are ready for inspection.

• Ensure research staff are up to date with GCP, human subjects protection, and protocol-specific training.

• Keep research SOPs, templates, and work instructions current and well-maintained.

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

• Lead the development and tracking of corrective and preventive actions (CAPAs).

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

• Monitor study budgets, invoiceable items, Sponsor payments, invoicing, and overall reconciliation.

• Facilitate research billing compliance by distinguishing routine care charges from research-related expenses.

• Generate enrollment, financial, and performance reports for the Principal Investigator and clinic leadership.

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

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

• Distribute workload across studies and keep track of staff capacity.

• Encourage collaboration between research and clinical staff.

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

• Execute additional duties that support the clinic's research program.

⛳️ Requirements

• A 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, including at least 2 years coordinating studies at a clinical research site.

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

• Proficient understanding of GCP, ICH guidelines, FDA regulations (21 CFR Parts 50, 54, 56, and 312/812), and HIPAA compliance.

• Familiarity with IRB submissions, informed consent processes, and regulatory documentation.

• Strong organizational skills with the ability to manage multiple studies, meet deadlines, and prioritize effectively.

• Exceptional written and verbal communication skills with Sponsors, monitors, patients, and clinical staff.

• Proficiency in Microsoft Office Suite.

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

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

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

• Experience with clinical research billing compliance and Medicare coverage analysis is preferred.

• Familiarity with the clinic's therapeutic areas is preferred.

• Experience in rare disease or pediatric studies is an advantage.

• Clinical skills such as phlebotomy, vital signs monitoring, or ECG, as permitted by licensure and scope of practice, preferred.

• Experience with FDA inspections or Sponsor audits is preferred.

• Ability to travel to Midwest clinical sites, particularly during study startup phases.

🏝️ Benefits

• 12-month contract-to-hire arrangement.

• Remote work opportunities for candidates located in the US.

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