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Clinical Trial Coordinator
3 weeks ago
Job Description:
Senior Research Associate RoleThe Senior Clinical Research Associate role is a crucial position in our organization, responsible for overseeing the smooth operation of clinical trials. As a key member of our research team, you will be instrumental in ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.
Your primary responsibility will be to monitor clinical trials, ensuring that all aspects of the study are managed efficiently and effectively. You will work closely with project managers to ensure that they are kept informed of all project developments, and you will be responsible for maintaining accurate records and documentation in compliance with project requirements.
This role also involves site qualification visits, where you will discuss protocol and other study documents with investigators and trial staff, ensuring that trial staff, facilities, and recruitment potential meet protocol requirements.
Additionally, you will support feasibility, site selection, and start-up activities, including preparing Human Research Ethics Committee submissions with sites.
As part of this role, you will also perform site initiation visits, training investigators and trial staff in protocol and data collection methods to ensure accurate and complete patient data.
Interim monitoring visits will also be a significant part of your responsibilities, ensuring adherence to protocol, verifying source data via source document verification, and meeting with site staff to ensure study procedures are conducted according to protocol and ICF GCP.
Lastly, you will oversee all aspects of study site management to ensure high-quality data, maintain eTMF filing, and manage timely site payments.
Required Skills and Qualifications
- Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
- At least 3-4 years' experience in monitoring clinical trials in CRO (preferable), Pharmaceutical and/or Biotechnology industry as a SCRA/CRA.
- Experience in managing early phase oncology trials is highly preferred
- Experience in EDC & CTMS
- Experience in all aspects of site-management from feasibility, start-up site selection to site close-out.
- Experience in contracts negotiation desirable.
- Experience in HREC submission preparation.
- Understanding and practical knowledge of ICH-GCP requirements particularly as required for site management.
- Willingness to travel to fulfill the requirements of the role.
Benefits
- Opportunities for career growth and professional development
- Collaborative and dynamic work environment
- Competitive salary and benefits package
- Recognition and rewards for outstanding performance
- Opportunities for internal and external training and development
Others
GenesisCare is an Equal Opportunity Employer. We value diversity and inclusion in our workplace and are committed to providing a safe and supportive environment for all employees. If you are passionate about innovation, collaboration, and delivering better life outcomes for patients around the world, we encourage you to apply for this exciting opportunity.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Hospitals and Health Care
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