Responsible for assisting and providing support to the members of the clinical operations project team (e.g., Clinical Project / Trial Managers, Head of Clinical Operations), in order to facilitate the management of the clinical trial processes including planning and execution of in-house or outsourced clinical trials.
The Clinical Trial Associate (CTA) assists in supporting the conduct of trials and may be responsible for managing specific study and operational tasks.
The CTA performs work within established protocols under general supervision.
Manage study specific PO Creation.
Liaise with internal coordinator to ensure Clintrials.gov is updated accordingly.
Participate in creation and distribution of specific study aides / materials and communications.
Collect & collate documents required for EC / IRB / HA submissions.
Assist Clinical Project / Trial Manager in tracking study related activities.
Agenda distribution & minute taking for internal study team meetings.
Support SUSAR distribution.
Maintain internal & external contacts lists.
Maintain knowledge and act as team super user for related systems (e.g. PO creation, TransPerfect eTMF).
Maintain up to date training record attending internal / external training as necessary.
Participate in inter-departmental workgroups to create or enhance processes.
Take on career developmental activities / tasks as necessary.
Under supervision of Clinical Project / Trial Manager or Clinical Head, may assist with tasks typically associated with study management such as site visits, clinical document / report review, ICF template generation and / or review, review IMP release packet prior to initiation, etc.
Up to 10% domestic and / or international travel may be required.
Bachelor's degree or nursing qualification. Scientific / health care field.
1+ years' experience in relevant field (eg. clinical site, CRO, Sponsor or clinical trial vendor).
Relevant experience in clinical research or related field.
Adequate Good Clinical Practice training.
General knowledge of regulatory requirements and guidelines governing clinical research.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
Company Profile :
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