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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial site activation, regulatory document management, and compliance with ICH-GCP standards. Proficient in coordinating site activities and maintaining effective communication with study teams and investigators.
Highest-signal resume keywords
Clinical Trial Site ActivationRegulatory Document ManagementICH-GCP ComplianceClinical Research MethodologiesFluency in Turkish and English
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 MethodologiesRegulatory SubmissionsDocument ManagementQuality Review ProcessesMedical Terminology
Soft Skills
Effective CommunicationTime ManagementTeam CollaborationProblem SolvingMentoring
Tools & Technologies
Microsoft SuiteCTMSETMFEISFShared Investigator Platform
Industry Keywords
Pharmaceutical IndustryCROEthics CommitteeAudit and InspectionSite Compliance
About the role
Key responsibilities & impact- Initiate and coordinate clinical trial site activation activities and essential document management
- Compile high-quality Investigator Initiation Packages leading to site initiation approval
- Prepare, validate, and submit regulatory documents including IIP, IRB approval forms, and FDA 1572/Attestation Forms
- Coordinate supporting roles and activities to ensure timely site activation
- Support central and local ethics committee packages, submissions, approvals, and communications
- Support investigators with local IRB workflows from preparation through approval
- Prepare, handle, and distribute clinical documentation and reports
- Support and implement activities in the Shared Investigator Platform
- Coordinate essential documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and annual ethics approvals
- Maintain IRB/Ethics and other committee activities
- File documents to the Trial Master File and assist with periodic quality reviews
- Update and maintain clinical trial systems tracking site compliance and performance
- Support investigator sites and study teams with audit and inspection responses
- Maintain communication with study teams and investigator sites; provide country/site updates
- Disseminate ethics approvals and communicate site approvals to stakeholders
- Conduct site personnel awareness sessions as needed
- Identify and resolve investigator site issues and support corrective and preventive actions
- Act as a subject matter expert or point of contact for site activation, systems, processes, and global initiatives
- Support mentoring of new hires
- Complete required training, timesheets, expense reports, and CV updates
- Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements
Requirements
What you’ll need- School diploma or certificate with equivalent combination of education, training and experience, or Bachelor of Science/Bachelor of Arts or equivalent
- Minimum 2 years relevant experience in clinical site management
- Experience working in the pharmaceutical industry or CRO in study site activation preferred
- Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations
- Must be fluent in Turkish and English
- Effective verbal and written communication skills
- Good technical skills and ability to learn and use multiple systems
- Knowledge of clinical research and development processes and clinical trial operational elements
- Understanding of quality expectations and right-first-time principles
- Understanding of basic medical terminology and GCP requirements
- Proficiency in computer operations, Microsoft Suite, CTMS, eTMF, eISF, document exchange portals, Shared Investigator Platform, and ethics/regulatory portals
- Ability to work independently and as a team member
- Ability to organize tasks, manage time and priorities, and multitask
- Ability to work flexible/off-hours in a global environment when applicable
- Able to travel as needed, including possible international travel
Benefits
Comp & perks- Temporary contract
- Full-time employment