CPC Clinical Research is an academically led Contract Research Organization dedicated to the management of clinical trials with the highest levels of quality and integrity. Competitive salary and benefits package, flexible schedules, and on-site exercise facilities.
Responsibilities: Supporting the functions and activities of the Colorado Prevention Center (CPC) in organizing and managing clinical research studies, including but not limited to:
- Conduct the following monitoring visits according to CPC standard operating procedures, Good Clinical Practice guidelines and applicable federal, state, and local regulations: Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits.
- Oversee drug accountability, storage and disposition at investigative sites.
- Resolve any required clarification of study data between the Biostatistics and Data Management department or the pharmaceutical companies’ data management department and the research sites to ensure the accuracy of data.
- Prepare reports and correspondence for project manager review and subsequent distribution to investigators and sponsors.
- Collect and maintain investigator regulatory documents.
- Conduct Site Endpoint Evaluation Visits when required by contract.
- Assure proper maintenance of required records for monitoring activities and required regulatory documents per CPC requirements.
- Submit appropriate travel expense report and receipts per CPC requirements.
- Follow the designated monitoring procedures and timelines set forth by the CPC SOP’s and contract.
- Participate in project-related and other departmental/CPC meetings as required.
- Help to produce study materials, including Case Report Forms, Study Procedure Manuals and source documents.
- Assist with the selection of qualified sites and investigators for participation in research protocols.
- Develop and present materials for investigator meetings and sponsor/CRO training.
- Train Clinical Research Associates at the CPC and staff at selected research sites.
- Provide other support functions as needed by the Research Operations Department.
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
- Understanding of the drug development process.
- Computer skills to include spreadsheet databases and word-processing.
- Experience with EDC and CTMS strongly preferred.
- Good interpersonal communication skills, good organizational skills and a great attention to detail are required. This individual must be able to work as a member of a team and possess good problem solving skills.
- Ability to complete tasks in an accurate and timely manner.
- Ability to manage conflicts and resolve problems effectively.
- Ability to discern priorities and requires minimal direction to accomplish day-to-day tasks.
- Nursing or bachelors degree preferred but not required.
- Three years experience in clinical trials research.
- At least one year experience as a CRA.
- Demonstrated mastery of CRA I responsibilities.
- Ability and willingness to travel up to 60%.