Clinical Research Associate
JOB TITLE: In-House Clinical Research Associate
REPORTS TO: Lead In-House Clinical Research Associate
Provide administrative and limited clinical support for large oncology multi-study clinical research program. The primary function of the In-House Clinical Research Associate is data entry completion of case report forms in conjunction with the management of the administrative aspects of the protocol.
- Complete case report forms and resolve queries in a timely manner as detailed in protocol(s).
- Coordinate the collection of data according to the research protocol and case report form guidelines.
- Work closely with research nurse coordinator and clinic staff to resolve data discrepancies.
- Document and report clinical study progress to external and internal study teams.
- Update site research staff of any changes in documentation requirements.
- Maintain calendar of study monitor schedule and provide data as requested by monitors and make timely corrections to research data as needed.
- Participate in site initiation, interim monitoring and study close out visits and sponsor and FDA initiated audits as needed.
- Maintain and audit clinical source data to ensure adherence to the research protocol.
- Responsible for the shipment of CRF materials and laboratory samples as needed, also prepares research materials in accordance with protocol.
- Manage all administrative aspects of Phase I, II, III and IV clinical trials.
- Special projects and other tasks as assigned.
- In collaboration with research nurse coordinator, educate research staff about data collection process.
- Maintain accurate screening and enrollment logs.
- Inform Principal Investigator of any monitoring or sponsor issues or concerns.
- Work closely and effectively with all other department personnel.
KNOWLEDGE, SKILLS & ABILITIES – Position requires the following minimal requirements:
Clinical research certification (or in progress)
- Knowledge of GCP and ICH regulations and guidelines
- Knowledge of oncology terminology is a plus
- Strong interpersonal and communication skills; excellent organizational skills
- Capable of critical thinking and have the ability to work independently and make decisions
- Detail oriented, have ability to multi-task, problem solve, and prioritize in a fast paced clinical environment
- Computer proficient including Word, Excel, PowerPoint and Outlook; ability to learn new software
- Bachelor’s degree in science related field
- 2 years in clinical research
Non-Exempt Position: salary based on experience