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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, ensuring compliance with Good Clinical Research Practice (GCP), and coordinating regulatory submissions. Proficient in data management, staff training, and maintaining regulatory documentation.
Highest-signal resume keywords
Good Clinical Research Practice (GCP)Clinical Trial ManagementRegulatory SubmissionsData ManagementStaff Training
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Research ExperienceFeasibility PlanningBiological Specimen ManagementRegulatory Document PreparationSOP RevisionVersion ControlMonitoring Visit PreparationStudy Amendment PreparationIRB CommunicationProtocol Compliance
Soft Skills
CollaborationCommunicationOrganizational SkillsProblem-Solving
Certifications & Qualifications
SoCRA Certification
Industry Keywords
Clinical TrialsIRBRegulatory ManagementAncillary CommitteesRadiation Safety
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Oversee day-to-day activities of clinical trials in accordance with Good Clinical Research Practice (GCP)
- Run portions of clinical trials from startup to closeout
- Coordinate screening, recruiting, enrolling, and consenting
- Conduct feasibility planning and data management
- Manage biological specimens
- Prepare for monitoring visits
- Prepare regulatory and IRB documents
- Ensure study procedures comply with protocols and applicable regulations
- Assist with orientation and training of new staff
- Develop workflows and training documents
- Revise SOPs and guidance documents
- Participate in work groups
- Serve as primary regulatory contact for assigned protocols
- Maintain regulatory binders/files and version control
- Coordinate submissions to ancillary committees, including Radiation Safety
- Communicate with IRB and sponsors regarding regulatory management
- Collaborate with study teams and sponsors to finalize documents based on PRMC and/or IRB recommendations
- Prepare and submit study amendments and continuing review applications
- Prepare regulatory files for audits and monitoring visits
Requirements
What you’ll need- High School Diploma/GED
- 5 years with High School Diploma/GED and SoCRA, or 6 years of clinical research experience
- 2 years with Bachelor’s degree and 2 years of clinical research experience
- 1 year with Master’s Degree and 1 year of clinical research experience
- Knowledge of Good Clinical Research Practice (GCP)
- Ability to lift and carry 40–50 lbs.
- Frequent to continuous standing/walking
- Ability to perform role-specific physical activities, including kneeling, bending, squatting, and CPR where required
Benefits
Comp & perks- Medical insurance, including prescription coverage
- Supplemental insurance
- Dental insurance
- Vision insurance
- Life insurance and AD&D insurance
- Short-term and long-term disability insurance
- Flexible spending accounts
- Retirement plans
- Tuition assistance
- Voluntary benefits with access to group insurance rates and discounts
- Tuition discounts at Thomas Jefferson University after one year of full-time service or two years of part-time service