Associate Clinical Trial Administrator
About The Position
Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. SUMMARY The Associate Clinical Trial Administrator provides the Clinical and Medical Affairs team with general administrative support responsibilities.
Requirements
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelorâs degree in a scientific or health care discipline preferred and/or training; or equivalent combination of education and experience
- 1-2 yearsâ 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
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 some cases, assists in the structure development of the tracking tools.
- 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.
Benefits
- Compensation also includes an annual bonus, flexible time off, and RSUs at offer!
- PROCEPTâs health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 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, and many more!
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
501-1,000 employees
