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SalaryPosition Summary:
The Clinical Trial Trainee (CTT) is a position designed to introduce and develop to the role of Clinical Trial Associate (CTA), Site Manager (SM) and/or Local trial Manager (LTM) to ensure optimal management of all procedures, documents, logistical and administrative tasks related to trial start-up, execution and closing of Clinical Trials. Ensures trial related activities are compliant with GCO SOPs, policies and local regulatory requirements.
Principal Responsibilities:
1. Provide administrative and logistical support to CTA, SM and/or LTM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies and local regulatory requirements.
2. Support the local study team in performing site feasibility and/or country feasibility. Collaborates with the Global Project Team, e.g. Clinical Trial Manager (CTM)/Global Trial Lead (GTL), local management/Country Head and other study team members, as required.
3. Maintain information in relevant systems, including VTMF filing.
4. Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
5. Support CTA, SM and/or LTM in collecting/preparing documents required for study start-up/ submission to IEC/IRB and/or HA.
6. Support CTA SM and/or LTM in collecting, processing and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
7. May assist team in conducting local investigator meeting or with making arrangements for the investigators participating in an international meeting.
8. Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.
9. Comply with all training requirements, company policies & procedures and all applicable laws and regulations. Always act aligned with Credo.
10. Ensure inspection readiness at all times.
11. May contribute to process improvement.
12. Support SM and within reasonable time be able to take on responsibility in executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/ study close-out according to SOPs, Work Instructions (WIs) and policies.
13. May contribute to onboard and mentor new CTTs or placement students.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Principal Relationships:
Primary Reporting Structure: Reports to Functional Manager (FM).
Primary interfaces: FM, LTM, CTA, and SM for assigned clinical studies.
Other Internal Interfaces: R&D Country Head, Clinical Trial Manager (CTM), LTM, SM, Quality & Compliance Manager/Specialist, Contracts & Grants, Clinical Trial Administrative team, Medical Affairs.
External Interfaces: Investigators and their delegates at site.
Qualifications
Education and Experience Requirements:
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
Proficient in speaking country language as well as English. Strong written and oral communication. Requirement for IT literacy relevant to Corporate and Clinical Operations.
Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Ability to perform activities in a timely and accurate manner.
