Clinical Affairs Project Specialist
Summary of Major Responsibilities
This position is responsible for technical, systems, processes, and data management related projects that support the execution of clinical trials. 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
- Serve as Clinical Affairs primary contact for systems administration (e.g., SampleMinded, CTMS); trouble-shoot system issues.
- Draft system user guides and train Clinical Affairs staff on system functionality.
- Facilitate system requirement development and systems improvement.
- Lead process improvement initiatives within Clinical Affairs.
- Analyze systems user needs to identify efficiencies/gaps. Assess cross-functional impact and integrate stakeholder recommendations/needs to streamline process flow.
- Communicate efficiencies/gaps cross-functionally.
- Lead data-driven projects.
- Work cross-functionally to analyze and provide input to clinical study tables and listings in support of regulatory reporting requirements.
- Interface with vendors, CROs, internal cross-functional teams and clinical sites. Articulate technical requirements as required.
- 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.
- Responsible for completing assigned tasks to support study timelines and metrics with minimal direction.
- Identify and report problems with systems and/or processes, investigate alternatives, and make recommendations for resolution and improvements.
- Must be able to work both independently and collaboratively as part of the clinical study team to meet study objectives and timelines.
- Author Clinical Affairs business processes, Standard Operating Procedures, and work instructions.
- 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).
- Thorough knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines.
- Strong attention to detail.
- Ability to organize, present, and convey problems or issues.
- Manage multiple priorities for various stakeholders in a cross-functional matrix environment.
- Adapt to rapid changes in priorities and identify ways to work together to achieve results needed for all requests.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint).
- 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.
- 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.
- At least 3 years of experience in a clinical research setting (Clinical Affairs Associate, Clinical Trials Associate, Study Coordinator, or similar) required.
- 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.
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. Applicable portions of the Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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