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About the role
- Associate Clinical Trial Administrator providing support to Clinical and Medical Affairs team at PROCEPT BioRobotics. Responsible for administrative tasks, document management, and project tracking related to clinical trials.
Responsibilities
- Updates the clinical project progress using tracking tools provided by the project leads from the Clinical and Medical Affairs team. This includes but is not limited to clinical study progress, Trial Master Files (TMFs), study essential documents, vendor and site payments, etc.
- In charge of the Engineering Change Order (ECO) process for documents created or updated by the Clinical and Medical Affairs team. This includes creating the ECO number, initiating the ECO and follow up all the way through document release. Might also help with creating redlined documents and drafting the change history under the supervision of the project lead.
- Prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed.
- Receives and reviews clinical study documents (including regulatory documents) from clinical trial sites for accuracy and compliance to company SOPs, ISO standards, and industry guidelines.
- Ensures all trackers are updated timely and accurately. Achieve historical versions of the trackers appropriately.
- Reviews all invoices from vendors related to Clinical and Medical affairs for accuracy per executed contracts. Communicate with vendors for any discrepancies on the invoices. Obtains approval from internal approvers and forwards the invoice together with the approval to the accounting team for payment process. Follows up with the accounting team regularly for payment process update.
- Assists with the organization and management of internal team meetings, investigator meetings and other trial-specific meetings.
- Performs general support to the Clinical and Medical Affairs team as needed.
Requirements
- Bachelor’s degree in a scientific or health care discipline preferred and/or training; or equivalent combination of education and experience
- 1-2 years’ experience in the medical device industry with involvement in clinical research activities preferred
- Superb verbal and written communications skills
- Excellent organizational skills along with strong attention to detail
- Ability to work both independently and collaboratively in a team environment
- Highly proficient with Microsoft office Suite
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
- Ability to utilize critical thinking to analyze problems which may require multiple factors and approaches
Benefits
- full medical coverage
- wellness programs
- on-site gym
- 401(k) plan with employer match
- short-term and long-term disability coverage
- basic life insurance
- wellbeing benefits
- flexible or paid time off
- paid parental leave
- paid holidays
- many more!
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