Research Protocol Specialist II Job in Rochester (Minnesota, USA, United States)

Job Description:

The Research Protocol Specialist II assists in the development and maintenance of the protocol document and process from initial receipt of participation through study completion, termination and/or publication. Responsibilities may include, but are not limited to: preparing drafts of Mayo Informed Consent Forms (ICFs), boilerplate financial disclosure forms and determining appropriate forms and documentation for Institutional Review Board (IRB) submission, such as participating modalities, investigational drug brochures, investigational new drug (IND) approvals, regulatory materials and draft addenda where appropriate. Position provides input to amendments and submits protocol modifications to the IRB within specified timeframe. Position coordinates with Mayo sites (Arizona, Jacksonville, Rochester) to determine participation in study where appropriate. Position independently determines changes necessary to forms and writes/distributes communications due to revisions in the protocol document and supporting paperwork. Position interacts regularly with the IRB on new protocol submissions, protocol amendments/modifications, adverse events and continuing progress reports. Position conducts training as necessary, participates on committees and task forces and provides input to standard operating procedures related to implementation, maintenance and continuing review. Position anticipates and carries out independent actions necessary to provide competent and professional support to meet the needs of patients, physicians, administrators, co-workers and others and initiates judgment in handling questions, phone calls and appointments. Position provides consultative guidance to Research Protocol Specialists I and Investigators and works cooperatively with a variety of personnel at all levels inside and outside of Mayo, including clinical investigators, other allied health personnel (e.g. Statisticians, Pharmacists, Research Study Coordinators, Legal, Finance, Laboratory, etc), representatives from the pharmaceutical industry, federal government agencies (e.g. FDA, NIH, OHRP) and other research organizations. #

Basic Qualifications:

Associates degree required with a minimum of 5 years experience in a medical or complex administrative setting.

Other Qualifications:

Bachelor's degree preferred. Must have the ability to work independently with minimal direction. Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills. Must have the capacity to comprehend complex structures and connections and be willing to adapt within a rapidly changing environ