CLINICAL TRIALS ASSISTANT - POSITION SUMMARY
Responsible for assisting the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.
To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director
To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals
To be familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems
To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival
To co-ordinate ordering/dispatch and tracking of trial materials (e.g. binders, notebooks, lab supplies, drug supplies) as appropriate
To assist in co-ordination of Investigator payments, if applicable
To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
To assist in the tracking and distribution of safety reports
To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes
To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations
Other duties as assigned
Proficiency in MS Word, Excel, PowerPoint, Outlook
Excellent written/oral communication skills as well as strong organizational and multi-tasking skills
Research or health care related academic or work experience preferable
REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES
Understand the job specific system and processes as defined by the company’s SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
Maintain corporate confidentiality at all times.