Clinical Project Associate
The Clinical Project Associate will be responsible for supporting clinical trial activities. He/she will have regular and frequent interactions with the internal team, Contract Research Organizations and clinical site staff to ensure effective project execution.
Essential Functions and Duties
- Assist in site management
- Closely monitor adherence to clinical protocols
- Monitor/track CRO activities and review monitoring trip reports
- Co-monitor clinical sites if applicable
- Manage adherence to clinical study plans and enrollment and data collection timelines
- Develop and document project-specific procedures, processes and trackers for assigned studies
- Maintain close communications with internal staff and CROs to help coordinate study activities
- Communicates with site staff throughout the duration of the study
- Develop and maintain tracking systems for clinical trials
- Provide timely and accurate reports of project status to team members
- Develop, prepare, and distribute materials (e.g. agendas) for project meetings
- Take and distribute meeting minutes for project meetings
- Assist in the development of clinical trial protocol summaries, protocols, Investigator brochure and informed consent documents
- Review regulatory and clinical documents
- Review invoices as needed
- Prepare and submit trial-related documents to the Trial Master File
- Provide support as needed for other clinical studies
- Maintain a high standard of professionalism, and confidentiality, in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively.
- Strong written and oral communication skills and above average computer skill knowledge using Outlook, Word, Excel and PowerPoint (MS Project a plus).
- Familiar with and comfortable reviewing clinical study-specific documentation.
- Thorough understanding of GCP, conduct of clinical trials, and medical/scientific language.
Education & Experience
- Bachelor’s degree (in a scientific field is preferred)
- Must have at least three consecutive years of experience working in clinical operations.
- CRA experience preferred. Oncology experience strongly preferred.
- Office environment
- Minimal Travel required