The Clinical Research Program Coordinator’s primary responsibility is the overall administrative coordination and management of research studies in the areas of Hematology/Oncology/BMT. The Clinical Research Program Coordinator will be responsible for managing elements of a clinical research in order to meet all of the protocol obligations while following ICH/GCP guidelines; departmental/institutional guidelines and standard operating procedures. These responsibilities include but are not limited to: implementation of protocol at time of startup, protocol compliance, source documentation, data collection and day to day management of study participants and the sponsor activities.
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1. Responsible for administrative management, organization of, and participation in program meetings and teleconferences, including scientific meetings with corporate and non-profit partners, teaching conferences, grand rounds, journal club, research seminars, and CME programs
2. Conducts clinical human subjects research as outlined in the study protocol; performing study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines adheres to Good Clinical Practices.
3. Prepares and processes human subject specimens for use in research studies. May need to ship specimens according to the study protocol. Maintains Safety Pack certification for shipment of specimen materials.
4. Works in collaborations with department/center investigators in the development of IRB protocols, grant submissions and scientific publications
5. Coordinates personnel needs for the program and projects; oversees and organizes training for study protocols within the Division of Hematology/Oncology/BMT.
6. Collects and controls research data and subject information and maintains accurate data collection of all study data; including tests and procedures related to study compliance.
7. May be responsible for administrative management of multiple protocols; plays a central role in the communication between NCH/RI and site; will act as liaison with other departments necessary to complete program projects (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.)
8. Manage the reporting to adverse events and report to IRB in a timely manner., ensuring sites are submitting accurate and timely IRB submissions, and maintain associated regulatory documents
9. Help facilitate creation of source documents that ensure systematic data collection and/or aid in protocol execution and management and record keeping
10. Collects and controls research data and subject information from sites as needed/requested; tracks screening and enrollment data across multiple sites/multiple projects
11. Provides monitoring, review and tracking of clinical data and preparation of study specific documents according to FDA regulations
12. QA process implementation, maintenance and documentation; data entry; and maintenance of regulatory documents for multiple sites; multiple protocols
13. Work with principal investigators at each site to establish multi-site monitoring plans for investigator initiated projects (If applicable)
14. Performs other duties and maintains flexible schedule as required
KNOWLEDGE , SKILLS AND ABILITIES REQUIRED
1. Bachelor's Degree or equivalent work related experience
2. Experience healthcare related field
3. Demonstrated organizational, and interpersonal skills.
4. Skills required:
• Strong organizational skills
• Exceptional interpersonal skills
• Excellent written and verbal communication
• Ability to filter information, discern importance and initiate plan for project completion
• Goal-oriented; self-directive
• Initiation, flexibility, motivation, creativity
• Ability to actively participate as a team player
• Working knowledge of PCs and word processing and data management software
MINIMUM PHYSICAL REQUIREMENTS Talking on phone/in person; frequently (34-100%) Typing on keyboard; frequently (100%) Sitting; frequently (34-100%) Standing/Walking; frequently (34-100%) Lifts objects weighing up to 25 pounds; occasionally (0-33%)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.