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Vacancy Details
Vacancy posted by: Colorado Prevention Center
Job Title: Senior Clinical Research Associate
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Vacancy details
Vacancy description:
Job Code:
Senior Clinical Research Associate
Job Title:
Senior Clinical Research Associate
Job Category:
Clinical Research
Contract:
Permanent
Discipline:
CRA
Country:
United States Of America
Location:
Colorado
Min experience:
5 years
Annual salary:
Negotiable
Apply by:
28 Nov 2008
Colorado Prevention Center
Job Title: Senior Clinical Research Associate
Supervisor: TBD
Responsibilities: Supporting the functions and activities of the Colorado Prevention Center (CPC) in organizing and managing clinical research studies, including but not limited to:
1. Assist in coordinating Clinical Research Associate staff, as well as providing resource information to CRAs in support for their monitoring and SEEV activities.
2. Selection of qualified sites and Investigators for participation in research protocols.
3. Training of Clinical Research Associates at the CPC and selected research sites.
4. Site support and monitoring for multi-center clinical trials according to the CPC standard operation procedures, Good Clinical Practice guidelines and applicable federal, state and local regulations.
5. Directing the 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.
6. Preparing reports and correspondence for the Project Managers review and subsequent distribution to Investigators, Institutional Review Boards/Ethics Committees and Sponsors.
7. Assuring proper maintenance of required records for monitoring activities, required regulatory documents and travel expenses per CPC requirements.
8. Collecting and maintaining Investigator regulatory documents.
9. Overseeing development of study materials including Case Report Forms, Study Procedure Manuals and source documents.
10. Developing and presenting material at Investigator Meetings and sponsor/CRO training.
11. Following the designated procedures and timelines set forth by the CPC SOP’s and contracts.
12. Providing CRA support functions as needed by the Research Operations department.
13. Conduct Site Endpoint Evaluation Visits when required by contract.
Qualifications:
1. Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
2. Computer skills to include spreadsheet databases and word-processing.
3. Excellent interpersonal communication skills, 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.
4. Possesses the ability to organize, instruct and supervise staff, while promoting group effort and achievement.
5. Must have the ability to coordinate and lead multiple projects simultaneously.
6. Ability to manage conflicts and resolve problems effectively.
7. Nursing or bachelors degree preferred but not required.
8. 5 years of experience in clinical trials research.
9. At least 3 years of experience as a CRA.
10. Able to discern priorities and requires minimal direction to accomplish day-to-day tasks.
11. Demonstrated mastery of CRA II responsibilities.
12. Ability and willingness to travel up to 60%
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