Clinical Affairs Associate
Summary of Major Responsibilities
This position is responsible for assisting in the execution of clinical trials by providing quality administrative and project management support. This position will coordinate with all members of the Clinical Affairs team and internal and external stakeholders to successfully execute the clinical study plans of the company.
Essential Duties and Responsibilities
- Collect essential documents and review for completeness and compliance with Standard Operating Procedures, the protocols and appropriate regulations; review Trial Master File (TMF) inventory for missing and expiring documents.
- Interacts with clinical study sites to support study start-up, execution, and close-out activities.
- 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.
- Review for completeness and route legal documents for execution. File all versions in document management database.
- Draft study documents (study trackers, templates, presentations, etc.) as requested.
- Support case report form (CRF) development, participate in user acceptance testing (UAT) for electronic data systems and review related data management documents, as applicable.
- Represent Exact Sciences as a customer advocate/liaison both internally and externally.
- Coordinate study start-up, execution, and close-out activities, or Investigator Meetings, as requested.
- Responsible for completing assigned tasks to support study timelines and metrics with minimal ongoing direction.
- Identify and report problems, investigate alternatives, and make recommendations for resolution and process improvements.
- Responsible for organizing cross-functional project meetings. Distribute agendas, take and distribute meeting minutes.
- Provide follow-up support and data collection for Research and Development teams to advance project objectives.
- Initiate purchase requests, liaise with Accounts Payable and vendors as needed.
- Provide support to Clinical Study Manager for clinical study budget review, tracking, and maintenance.
- Must be able to work both independently and collaboratively as part of the clinical study team to meet study objectives and timelines.
- Author and provide input to Clinical Affairs business processes.
- Maintain a working understanding of current SOPs, work instructions, applicable regulations and guidance documents, such as FDA Code of Federal Regulations (CFR) and International Council on Harmonisation (ICH), Guideline for Good Clinical Practices (GCP).
- Maintain applicable clinical study data in Clinical Trial Management System.
- 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 - create and modify spreadsheets, create complex formulas, ); 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.
- Ability to frequently and accurately communicate with co-workers, 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.
- Analytical, problem solving and decision-making skills.
- Excellent attention to detail and organizational skills.
Education and Experience
- Bachelor’s degree in the health or life sciences. Experience in a healthcare, clinical, or science related field preferred.
- At least one (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.
- Ability to travel (by land and air) on occasion.
- Ability to lift and move up to 40 pounds on an occasional basis.
We are 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. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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