| Understands and knowledgeable of policies, procedures, and regulations governing human subject?s research and incorporates them in securing approval for and the conduct of research.|
Implements, coordinates, manages and reports to the Institutional Review Board (IRB).
Implements, coordinates and manages clinical research operations.
Establishs and maintains communication with Investigators, research staff, study sponsors, research participants and their family members, and representatives of professional organizations associated with the conduct of the research.
Serves as an advocate for the human subjects by establishing and maintaining compliance in the conduct of the research protocol.
Actively identifies and participates in training, education and development activities to improve own knowledge and performance to sustain and enhance professional development.
Completes assigned goals.
|Responsible for coordinating the conduct of research protocols, assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, and BMHCC and BCRI Policy and Procedures. This includes the planning, development, coordination and evaluation of the clinical research from planning to study close-out. The CRC is responsible for specific protocol implementation and management, patient management including patient recruitment, screening, scheduling and enrollment/randomization, collecting and processing data via paper and electronic format. The CRC performs or implements processes to assure study-related procedures are performed as required and objectives and timelines are met. The CRC may act as a liaison between the hospitals, the Institutional Review Boards (IRB), study sponsors and all investigators. This person will also assist in collaborating with the Research Assistant and Data Manager. The CRC will also be responsible for the delegation of duties as needed. The CRC will understand and practice within the scope of Federal Regulations in regards to clinical research, understand Good Clinical Practice, be CITI trained and will understand and follow the policies and procedures for BMHCC and BCRI. Performs other duties as assigned.|
| Bachelor's degree in a related field|| || |
| 2 years medical and/or research background required.|| || |
| || BLS|| |