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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in overseeing clinical trials, ensuring compliance with Good Clinical Research Practice (GCP), and managing clinical data. Proficient in training research staff, conducting quality control assessments, and preparing regulatory documents.
Highest-signal resume keywords
Clinical Research CoordinationClinical Data ManagementGCP ComplianceSoCRA CertificationOncology Clinical Research Experience
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 Trial MonitoringQuality AssuranceFeasibility PlanningBiological Specimen ManagementData ManagementElectronic Capture Database DesignRegulatory Document PreparationSOP DevelopmentQuality Control AssessmentsClinical Trial Audits
Soft Skills
Training and SupervisionIndependent WorkOrganizational Skills
Certifications & Qualifications
SoCRA Certification
Industry Keywords
Good Clinical Research PracticeClinical TrialsRegulatory InspectionsIRB DocumentsSubject Logs
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Oversee the 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, data management, and biological specimen management
- Prepare for monitoring visits and prepare regulatory and IRB documents
- Ensure study procedures comply with protocols and applicable regulations
- Train and supervise research staff on clinical trial procedures and GCP
- Maintain subject logs, track expenses, and submit monthly payment documentation to the Grant Administrator
- Perform quality control assessments and organize clinical trial data documentation
- Design electronic capture databases when appropriate and manage collected data
- Assist with staff orientation, workflow development, training documents, SOP/guidance document revision, and work groups
Requirements
What you’ll need- High School Diploma/GED and SoCRA certification and six years of clinical research experience; or Bachelor’s degree and two years of clinical research experience; or Master’s degree and one year of clinical research experience
- Four or more years of clinical research experience preferred
- Experience in clinical research coordination, clinical data management, clinical trial monitoring, quality assurance, or a related area
- Experience with clinical trial audits, regulatory inspections, GCP, and applicable clinical research regulations
- Oncology clinical research experience preferred
- Experience developing or delivering training and preparing standard operating procedures or guidance documents
- Ability to work onsite three days per week and remotely two days per week after training and demonstrated ability to work independently
- Ability to work Monday through Friday, with workdays potentially beginning as early as 7:00 a.m.
- Ability to lift and carry 40–50 lbs.; frequent to continuous standing and walking
- SoCRA certification is required for the high-school-diploma pathway
Benefits
Comp & perks- Medical insurance, including prescription coverage
- Supplemental insurance
- Dental insurance
- Vision insurance
- Life and AD&D insurance
- Short- 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