CLINICAL RESEARCH COORD B/C

Duties: Clinical Research Coordinator B: With minimal supervision, coordinate Phase I-IV clinical trials. Support ongoing clinical trials in medical and head and neck oncology by consenting patients, maintaining databases, completing adverse events reporting to regulatory authorities and industry sponsors. Responsible for extraction of data from clinical records, coordination of research related testing and sample processing with the patient and rest of the research staff. Entry of all data in a timely fashion into both university and industry databases. Will help develop and work with study budgets to coordinate accurate billing for patient research activities. Will be completely responsible for overseeing successful execution of research projects assigned. Will accurately extract data from databases in form usable for manuscript or other type of publication. Will be responsible for all regulatory filings required for maintaining active status of the trial with the IRB, the Clinical Trials Scientific Committee and Data Safety Monitoring Committees, and be able to work effectively with study monitors and auditors on an as needed basis. Experience with handling research blood samples preferred but not required.

Clinical Research Coordinator C: Independently manage Phase I-IV clinical trials for the Center for Rare Cancers and Personalized Therapeutics. Support ongoing clinical trials in medical and head and neck oncology by consenting patients, maintaining databases, completing adverse events reporting to regulatory authorities and industry sponsors. Responsible for extraction of data from clinical records, coordination of research related testing and sample processing with the patient and rest of the research staff. Entry of all data in a timely fashion into both university and industry databases. Develop study budgets to coordinate accurate billing for patient research activities. Will be completely responsible for overseeing successful execution of research projects assigned. Will accurately extract data from databases in form usable for manuscript or other type of publication. Prepare and process all IRB, CROs, and pharmaceutical companies regulatory documentation, organize and maintain all documentation, resolve data and regulatory queries with sponsors, IRB, and CROs. Mentor other coordinators and serve as a role model.

Qualifications: Both levels of this position require effective problem solving abilities; communication and writing skills are critical. Must possess the ability to work as part of a team, as well as independently.

Clinical Research Coordinator B:
* The minimum of a Bachelor's degree and 2 years to 4 years of experience or equivalent combination of education and experience required.
* Ability to coordinate Phase I-IV clinical trials with minimal supervision

Clinical Research Coordinator C:
* The minimum of a Bachelor's degree and 4 or more years of experience or equivalent combination of education and experience required.
* Ability to independently manage Phase I-IV complex clinical trials and ability to mentor coordinators
* Ability to independently manage Phase I-IV complex clinical trials and ability to mentor coordinators Knowledge of IRB and human research protection regulations and experience with regulatory processes is required

Reference Number: 40-26464

Salary Grade: 026/027

Employment Type: Exempt

Org: OT-Otorhinolaryngology

Special Requirements:

Job Family: I-Technical/Professional Research