Research Protocol Spec 2 Job

Company Name:
Mayo Clinic
Job Posting Number: 33502BR
Job Posting Title: Research Protocol Spec 2
Job Posting Category: Research
Work Site: MN - Rochester
Department: CRO Cancer Center
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. 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 environment. Requires strong organizational skills and the ability to prioritize and handle a variety of tasks simultaneously. Must have the ability to exercise good judgment in ambiguous situations under pressure and have strong coping skills.
Other Qualifications:
Experience with medical terminology and proficiency with use of technical office equipment and standard Mayo software and databases is preferred.
License or Certification:
Benefit Eligible: Yes
Exemption Status: Non-exempt
Hours/Pay Period: 80
Schedule Details: Mon-Fri
Weekend Schedule:
Compensation Detail: Education, experience, and tenure may be considered along with internal equity when job offers are extended. The minimum pay rate is $19.05 per hour.
Staffing Specialist: Janice Tesch
Company Statement:
Mayo Clinic provides the highest quality patient care by placing the needs of the patient first. You''ll discover a culture of teamwork, professionalism and mutual respect -- and most importantly, a life-changing career. We invite you to join our diverse team as we provide health, hope and healing to people from all walks of life.
Mayo Clinic is an equal opportunity educator and employer (including veterans and persons with disabilities).
Req ID: 33502BR
Date: Mon, 24 03 2014 00:00:00 GMT
Country: US
State: MN
City: Rochester
Postal Code: 55901
Locale: en_US

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