New
Research Project Coordinator
![]() | |
![]() United States, Indiana, Lafayette | |
![]() 1345 Unity Place (Show on map) | |
![]() | |
Overview
SCOPE: Under the direct supervision of a physician or nurse, facilitates activities in support of research projects or studies. Oversees maintenance of information for all patients who are registered on approved clinical research protocols. Oversees data management functions for the department. Practices in compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards. ESSENTIAL DUTIES AND RESPONSIBILITIES: -Under the direction of a physician or nurse, screens referred patients for potential protocol eligibility. -Under the direction of a physician, presents trial concepts to patient and obtains informed consent. May assist in protocol-specific patient education activities. Presents trial concepts and details to the patients, and participates in the informed consent process under the direction and supervision of the physician. May assist in protocol specific education activities. -Reviews study information with patient as needed, and directs questions to nurse or physician. Facilitates ongoing communication between patient and medical staff regarding progress, side effects and related questions. -Coordinates patient scheduling for consultations, diagnostic tests or procedures and future appointments per protocol. -Registers patients on protocols and maintains patient database and related information. -Under the direction of a physician or nurse, coordinates the ordering of patient medication and supplies in accordance with protocol. -May assist with monitoring of project/study budget information. -Oversees accurate data collection, entry, and timely submission. -Performs patient follow-up and data management per protocol. Maintains strict confidentiality according to practice policies, HIPPAA guidelines, and other applicable law. -Participates in all site monitoring visits and audits. Participates in local quality assurance program and develops appropriate action plans for quality improvement. -Maintains protocol regulatory documents in compliance with USOR SOP. Communicates, reviews, and documents weekly Regulatory Memoranda with physicians and other clinic staff as appropriate. -May provide guidance and daily work direction to support staff in the Clinical Research department including Clinical Research Assistants and Data Coordinators. MINIMUM QUALIFICATIONS: Bachelor*s degree in the Life Sciences or related field and minimum two years related experience. Prior oncology research experience strongly preferred. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision correctable to 20/20. Requires occasional lifting of up to 30 pounds. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office environment and requires frequent interaction with research staff, physicians, study sponsors and regulatory agencies. Work will require limited travel by air or automobile, approximately 15% of time. |