ICON plc is a global leader in healthcare intelligence and clinical research, committed to shaping the future of clinical development. With a focus on innovation and excellence, ICON fosters a diverse and inclusive work culture. Joining ICON means being part of a mission-driven organization that helps advance clinical trials and brings life-changing pharmaceutical and biological products to patients worldwide.
Responsibilities in the Job
As a Study Start-Up Associate (Level I & II), you will play a crucial role in facilitating the initiation of clinical trials by ensuring that research sites and investigators are prepared for trial execution. Key responsibilities include:
- Preparing and submitting essential regulatory documents, including clinical trial applications and ethics committee submissions.
- Coordinating with internal and external stakeholders to secure necessary study approvals.
- Maintaining accurate records of regulatory submissions and approvals.
- Supporting the development of study-related documents, such as protocols, informed consent forms, and investigator brochures.
- Reviewing and negotiating clinical site investigator contracts and budgets.
- Acting as a liaison between investigative sites, sponsors, and internal personnel.
- Providing training and mentorship to junior team members and acting as a consultant on budget and contract development processes.
Qualifications Required
Candidates should meet the following criteria:
- A minimum of 2-6 years of experience in clinical research, specifically in essential document review for study start-up.
- Thorough knowledge of ICH-GCP guidelines.
- Experience working across multiple countries is an added advantage.
Skills Needed
- Strong negotiation and communication skills, particularly for handling Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries.
- Proficiency in reviewing and approving country and site-specific informed consent forms (ICFs).
- Ability to coordinate effectively with diverse teams and stakeholders.
- Detail-oriented with excellent organizational skills to manage regulatory documentation.
