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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 start-up and site activation, with a strong understanding of regulatory requirements and documentation processes. Proven ability to manage multiple studies and collaborate effectively with cross-functional teams.
Highest-signal resume keywords
Clinical Trial Start-UpSite ActivationRegulatory SubmissionsCTF Submission ExperienceStakeholder Coordination
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Document PreparationClinical Trial ApplicationsEthics Committee SubmissionsProtocol DevelopmentInformed Consent FormsInvestigator BrochuresStudy Start-Up MeetingsDocumentation ReviewSubmission CoordinationAttention to Detail
Soft Skills
Excellent CommunicationInterpersonal SkillsOrganizational SkillsCollaborationTime Management
Industry Keywords
Life SciencesClinical ResearchRegulatory AuthoritiesEthics CommitteesIRBs
About the role
Key responsibilities & impact- Facilitate the initiation of clinical trials while ensuring compliance with regulatory requirements
- Deliver site start-up and activation work to a high standard
- Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
- Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
- Maintain accurate and up-to-date records of regulatory submissions and approvals
- Support study teams in developing protocols, informed consent forms and investigator brochures
- Participate in study start-up meetings and provide input on regulatory requirements and timelines
Requirements
What you’ll need- Bachelor's degree in Life Sciences or a related field
- Demonstrated experience within Study Start-Up / Site Activation in a clinical research environment
- Proven experience independently completing CTF 1, CTF 2 and CTF 3 submissions from start to finish
- Experience preparing, reviewing, coordinating and submitting all required documentation across the CTF submission stages
- Strong understanding of regulatory and documentation requirements associated with clinical trial start-up and site activation
- Experience coordinating with sites, Ethics Committees/IRBs, Regulatory Authorities and internal study teams, as applicable
- Ability to independently manage multiple studies, sites, submission requirements, timelines and follow-up activities in a fast-paced environment
- Strong organisational skills and attention to detail
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Legal right to work in South Africa
- Willingness to work from the office 2–3 days per week
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways