Prime Responsibilities of A Clinical Trial Assistant in Clinical Trials

Clinical trials are designed to test new medications and medical devices for safety and efficacy. Trials are highly regulated and thoroughly monitored, which results in a significant record-keeping and compliance burden. This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

As a Clinical Trial Assistant (CTA) you have to assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.

✔️Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).

✔️Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.\

✔️Support the Clinical Operations teams with ongoing conduct of studies.

✔️Should be  familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.

✔️Familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.

✔️Assist project teams with study specific documentation and guidelines as appropriate.

✔️Must Know how 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 process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.

✔️To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).

✔️To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.

✔️To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.

✔️To copy and route incoming correspondence, internal documentation, CRFs, etc., 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 co-ordinate document translation, if required.

✔️To attend project team meetings and generate meeting minutes.

✔️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.

✔️To assist with the coordination of team member tracking.

✔️The Clinical Trial Assistant provides the administrative support to the clinical research teams in the full spectrum of the research activities such as pre-clinical research, study start up, site management and site closure. 

✔️The Clinical Trial Assistant assists in gather and the preparation of documents for clinical trial applications for the submission and approval from the competent authority and ethical committees.

✔️The Clinical Trial Assistant Is responsible for the correct filing and archiving of clinical trial documents, and the maintenance of study files.

✔️Provides support in meeting activities such as organizing and planning of meetings (e.g. investigator-, project-, team- meetings), and provide meeting minutes.

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Communication

✔️Ensure relevant documents are available for all research patients, adhering to Medical Records tracing systems

✔️Report untoward incidents to the appropriate Person in Charge and, where related to patient care, complete the Incident Report Form under the supervision of a Registered Nurse/other Professional

✔️Participate in completing all documentation relating to research patient participation, including hospital records, Case Report Forms (CRF’s) and electronic research records

✔️Ensure relevant documents are available for all research patients, adhering to Medical Records tracing systems

✔️Deal with telephone enquiries from staff, patients and carers giving responses where this is within the post holder’s area of knowledge and ensuring that appropriate personnel are informed if appropriate in order for further actions to be taken.

✔️Interact with trial participants in relation to the requirements of the clinical trials and be able to work without supervision in some areas.

Teamwork

✔️Under the guidance of a team leader, where necessary provide day-to-day support to other members of staff and members of staff new to the work area

✔️Work closely with Clinical Investigators, Research Nurses and other members of research teams to maintain holistic support for all clinical trial participants, thus facilitating a high quality research service.

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