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Core Competencies
Role fitCore 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
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Research ExperienceProtocol Feasibility AssessmentStudy BudgetingRegulatory DocumentationParticipant RecruitmentEDC Data EntryGCP KnowledgeClinical SkillsFDA RegulationsHIPAA Compliance
Soft Skills
Strong Organizational SkillsExcellent Communication SkillsCollaborationLeadership
Tools & Technologies
Microsoft OfficeEDC SystemsCTMSERegulatoryEHR Systems
Certifications & Qualifications
ACRP CertificationSOCRA Certification
Industry Keywords
Clinical TrialsSponsor NegotiationsClinical Research Billing ComplianceRare Disease StudiesPediatric Studies
Tech Stack
Tools & technologiesGoogle 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
- 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
- Develop and negotiate study budgets with Sponsors
- Lead site initiation visits and activate sites after approvals, training, and supplies are in place
- Oversee day-to-day conduct of active studies and ensure compliance with protocol, 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 and specimen collection, processing, storage, and shipment
- Act as primary contact for Sponsors, CROs, and monitors; host monitoring visits and resolve findings
- Maintain inspection-ready regulatory binders and electronic files
- Ensure research staff maintain current training and that the PI delegates responsibilities appropriately
- 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
- Ensure applicable studies are registered and updated on ClinicalTrials.gov
- Track study budgets, invoiceable items, Sponsor payments, and research billing compliance
- 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 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 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
- Candidates must be able to visit Midwest clinical sites, especially during study startup
- 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
Benefits
Comp & perks- 12-month contract-to-hire arrangement
- Remote work for US-based candidates
- Periodic site visits rather than a fixed home location requirement