Clinical Affairs Associate
Summary of Major Responsibilities
This position is responsible for assisting in the execution and management of clinical trials by providing quality administrative and project tracking support. This position will coordinate with all members of the Clinical Affairs Team to successfully execute the clinical study plans of the company.
Essential Duties and Responsibilities
- Working under supervision, manage and maintain the trial master file (TMF) for assigned studies.
- Collect essential documents and review for completeness and compliance with SOPs, the protocols and appropriate regulations; review TMF inventory for missing and expiring documents.
- Create and maintain study related trackers, including but not limited to, enrollment, study supplies, receipt of samples, and site information.
- Coordinate the ordering, tracking, and accountability of clinical supplies, including investigational product materials, equipment, and special-order items as requested.
- Drafts study documents (study trackers, templates, presentations, etc).
- Represents Exact Sciences as a customer advocate/liaison both internally and externally.
- Coordinates principal investigator meetings and events.
- Responsible for completing assigned tasks in a timely manner, requiring minimal ongoing direction.
- Identifies and reports problems, investigates alternatives, and recommends possible courses of action depending on the severity and impact of the issue.
- Must be able to work both independently and collaboratively as part of the clinical study team to meet study objectives and timelines.
- Maintain a working understanding of current SOP’s, work instructions, applicable regulations and guidance documents, such as FDA Code of Federal Regulations (CFR) and International Council for Harmonisation (ICH) Guidelines on Good Clinical Practices (GCP).
- General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines.
- Ability to organize, present, and convey problems or issues.
- Experience in using basic software applications including Microsoft Office (Word - generate documents and tables, Excel - able to create and modify spreadsheets, create complex formulas, etc.); Email – preferably Outlook; and various search engines for conducting Internet searches.
- Strong verbal and written communication skills.
- Effective presentation skills.
- Ability to interface and work effectively within team and department with changing priorities.
- Analytical, problem solving and decision-making skills.
- Excellent attention to detail and organizational skills.
Education and Experience
- Bachelor’s degree in a science related field and a healthcare, clinical, or scientific background preferred.
- At least 1 year of experience in a clinical research setting (Clinical Trials Assistant, Study Coordinator, or similar), preferred
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to sit and/or stand for an extended period of time.
- Ability to travel (by land and air), both domestically and internationally, on occasion.
- Ability to frequently and accurately communicate with employees, customers, and vendors, via the telephone or by email.
- Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
- Ability to manage multiple deadlines.
- Ability to lift and move up to 40 pounds on an occasional basis.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email [email protected].
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