Clinical Research Coordinator B/C

Responsibilities

• Coordinate the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the ACC CRU Research Team.
• Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens.
• Coordinate completion and appropriate documentation of new study staff training during any staffing transitions or for coverage purposes.
• Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.
• Interface with regulatory authorities, Sponsors and cooperative groups as directed by the ACC CRU Research Team Program Manager.
• Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential participants in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.).
• Develop, schedule and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP) (e.g. scheduling participant visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).
• Show vigilance in patient safety, protocol compliance and data quality, and participate in data organization for research publications, with potential for co-authorship.

Qualifications

• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
• The successful candidate must have:
• (1) practical experience coordinating the day-to-day activities of multiple research projects;
• (2) effective verbal and written communication skills;
• (3) ability to learn new methods quickly and multi-task;
• (4) demonstrated ability to work as part of a team as well as independently;
• (5) knowledge or experience in cancer preferred but not required;
• (6) ability to work flexible hours;
• (7) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.