Clinical Trial Manager – Contract to Hire

TransPerfect

. Evaluate new studies with the Principal Investigator and assess protocol feasibility, patient population, staffing, equipment, and space .

Posted 11/9/2026full-timeRemote • New York • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical research coordination, including protocol feasibility assessment, regulatory compliance, and participant management. Proficient in budget development, staff supervision, and maintaining inspection-ready documentation.

Highest-signal resume keywords

Clinical Research CoordinationRegulatory ComplianceBudget DevelopmentStaff SupervisionIRB Submissions

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Research ExperienceProtocol Feasibility AssessmentStudy BudgetingRegulatory DocumentationEDC Data EntryAdverse Event ReportingSpecimen CollectionClinical SkillsGCP KnowledgeFDA Regulations

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsLeadership AbilitiesCollaboration SkillsProblem-Solving Skills

Tools & Technologies

Microsoft OfficeEDC SystemsCTMSERegulatory SystemsEHR Systems

Certifications & Qualifications

ACRP CertificationSOCRA Certification

Industry Keywords

Clinical TrialsPatient RecruitmentComplianceRare Disease StudiesPediatric Studies

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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 review of Clinical Trial Agreements and Confidentiality Agreements with clinic leadership and legal counsel
Develop and negotiate study budgets with Sponsors
Lead site initiation visits and activate sites after approvals, training, and supplies are complete
Oversee day-to-day conduct of active studies and ensure compliance with protocols, GCP, FDA regulations, HIPAA, and clinic policies
Oversee participant recruitment, screening, consent, enrollment, scheduling, and retention
Ensure accurate and timely source documentation and EDC data entry; oversee query resolution
Ensure adverse events, serious adverse events, and protocol deviations are documented and reported on time
Oversee investigational product accountability, including receipt, storage, dispensing, temperature monitoring, and return or destruction
Oversee specimen collection, processing, storage, and shipment, including staff shipping training
Serve as primary contact for Sponsors, CROs, and monitors; host monitoring visits and resolve findings
Maintain inspection-ready regulatory binders and electronic study files
Ensure research staff maintain current GCP, human subjects protection, and protocol-specific training
Maintain and update research SOPs, templates, and work instructions
Prepare 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
Track study budgets, invoiceable items, Sponsor payments, invoicing, and reconciliation
Support research billing compliance by separating routine-care charges from research-related charges
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
Foster collaboration between research staff and clinical staff
Recommend improvements to research processes, recruitment, and efficiency
Perform other duties supporting the clinic's research program

Requirements

What you’ll need

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 simultaneously
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
Current ACRP (CCRC, CCRP) or SOCRA (CCRP) certification preferred
Experience with study budgeting, contract review, and Sponsor negotiations preferred
Experience with clinical research billing compliance and Medicare coverage analysis preferred
Experience in the clinic's therapeutic areas preferred
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 preferred
Experience with FDA inspections or Sponsor audits preferred
Ability to travel to Midwest clinical sites, especially during study startup

Benefits

Comp & perks

12-month contract-to-hire arrangement
Remote work for US-based candidates
Periodic site visits rather than a specific home location requirement