JOB OBJECTIVE: The Clinical Trials Associate (CTA) will support the clinical research development team in the day to day study execution and conduct of clinical trials. This individual will work closely with the Director of Clinical and Translational Research, Clinical Trials Manager and the clinical research study team to ensure key projects are defined and implemented according to the clinical research operations plan, in accordance with FDA regulations, Good Clinical Practice (GCP), and sponsor standard operating procedures (SOPs).
1. Assist Clinical Trials Manager in all operational aspects of clinical research activities from protocol concept through study close out in accordance with SOPs, regulations, ICH/GCP and study specific protocols, manuals and procedures.
2. Assist in the Site Selection/Qualification planning, including site visits.
3. Assist Clinical Trials Manager with CRO, CRA and other third party vendor training on protocols and practices.
4. In collaboration with the CRO and Clinical Trials Manager, collect and review site regulatory documents.
5. In collaboration with the CRO and Clinical Trials Manager, assist with developing, maintaining, and managing study related documents and documentation.
6. Assist with eTMF filing and auditing for both internal, CRO and site files.
7. Review Electronic Data Capture forms and process, developed by the CRO, to ensure alignment with the protocol and study specific requirements.
8. Set up and maintain tracking systems and tools and report study metrics to support the clinical research, cross-functional and larger Usona teams.
9. Assist with managing and tracking clinical and non-clinical supplies.
10. Assist in coordinating investigator meeting planning, including preparing meeting materials and on-site meeting implementation; may present at investigator meetings.
11. Along with the Clinical Trials Manager, participate in regularly scheduled CRO and other third party vendor meetings.
12. Assist in planning and presenting at internal team meetings and providing written documentation of meetings related to study progress.
13. Provide logistical support to a clinical trials team.
14. May have some clinical research monitoring interface with CRAs and study sites.
15. Assist other staff as requested and perform other related work, as needed, including but not limited to: IND submissions, reporting and compliance, developing and assisting with study site contractual agreements, and sponsor and site budgets.
16. Perform other job related duties, as necessary, as assigned by the Director of Clinical and Translational Research and Clinical Trials Manager.
17. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Bachelor’s degree with combination of education/experience in science or health-related field required.
2. At least 2 years of clinical trial experience, preferably sponsored research. Industry experience a plus.
3. Current Certified Clinical Research Professional (CCRP) certification (or equivalent), or will receive CCRP certification within 2 years of employment.
4. Working knowledge of GCP/ICH guidelines and the clinical development process.
5. Ability to work independently with minimal supervision and prioritize work to ensure the completion of essential deadlines.
6. Strong planning, communication, and organizational skills.
7. Proficient in the use of Microsoft Office.
8. Willingness to travel domestically; some international travel may also be required.
1. Ability to use telephone and computer equipment.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.