Mar 21 - Sterling Institutional Review Board Atlanta, GAProtocol AnalystResponsibilities in this role include:◼ Perform expedited reviews of new, modified and continuing research that meet regulatory and institutional requirements. Perform eligibility reviews of physicians applying for principal investigator for research studies. Advise sponsors of board actions, and outstanding board action requirements, and medical licensure issues.◼ Maintain knowledge of regulation, policies and guidance for the review of research.◼ Conduct exemption determinations for projects eligible for exemption from IRB review, make determination assessments of projects that do not constitute human subjects research, and provide ethical evaluations of non human subjects research.◼ Maintain communication with staff on the status of review items.◼ Periodically attend convened IRB meetings to make recommendations on research projects based on expertise and experience. Present items reviewed and determined to be ineligible for expedited review.◼ Assist with delivery of educational programs pertaining to regulatory compliance in human research protections and IRB review processes for members of the IRB and administrative staff.◼ Prepare assigned sections of the IRB minutes.

 Oversees the review of all industry-sponsored drug and device, as well as investigator initiated research. This includes, but is not limited to, new and existing protocols, internal and external serious adverse events, safety alerts (MedWatch, CIOMS), protocol deviations, modifications, continuing review, emergency use and compassionate use requests, and source documents.  Maintains communications with principle investigator and study coordinators. Advises principle investigators and/or study coordinators about protocol submission requirements, assist with modifications to be made to new or existing protocols, and ensures completeness of protocol submissions, as advised by DHHS and federal guidelines. Triages protocol submissions for expedited and full board review. Advises study coordinators, nurses and doctors of the status of studies and generate reminders in advance of board meetings.  Prepares the agenda, protocol items for review, and distribute meeting packets to IRB members for bi-monthly board meetings. Monitors and manages conflict of interest reports from investigators and IRB staff per IRB policies and procedures. Creates, maintains and archives comprehensive IRB minutes and documents concerning IRB functions and meetings. Generates approval, contingent approval, acknowledgment, suspension of all activity, and expedited letters of IRB determination from IRBANA.  Provides IRB education to principle investigators, coordinators and IRB members. Maintains and updates IRB member rosters. Recruits new IRB members and submits to the Hospital Board for review and approval.  Invoices, receives and manages all IRB accounts receivable and accounts payable. Submits quarterly stipend/honorarium requests. Maintains IRB member honorarium documentation in Tract Manager. Also responsible for maintaining the IRBANA database.

Audit and input all study forms and requests into IRBANA in preparation for agenda for bi-monthly board meetings. Advised principle investigators and/or study coordinators of modifications to be made to new or existing protocols as advised by DHHS and federal guidelines. Generated approval, contingent approval, acknowledgment, suspension of all activity, and expedited letters from IRBANA. Advised study coordinators, nurses and doctors of the status of studies and generate reminders in advance of board meetings. Participated in IRB education of principle investigators and coordinators. Report to the IRB Administrator.  Assigned as Ambassador of One in the Spirit contribution campaign. Volunteered with Charis House in building affordable, low-income housing.

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MEPS, Honolulu, HI. Physical exams for those entering any branch of the military. Traveled to American Samoa to perform physical exams for the Army/Army Reserve. Performed physicals for all branches of service for applicants wishing to join the military. Instruct applicants in filling out the proper paperwork pertaining to the branch of service they are joining. Performed BAT for alcohol consumption, vital signs, drug coordinator, pregnancy testing-urine and/or blood, vision testing, hearing testing, HIV blood draw, height/weight and body fat taping, orthopedic maneuvers to test strength and flexibility, female standby for CMO. Experienced in MIRS and CHCS systems. Deployed to American Samoa to perform physicals on new recruits and reservists. CPR and Audiogram certified. Awarded Civilian Employee of the Half Year and Civilian Employee of the Year for 1999. EEO assistant to the 1Sgt.

 Newport, RI. Female/childrens ward. Intensive care Unit. 21 ABMC, Del Mar, Camp Pendleton, CA. Field Medical Service School. Kinser Group Aid Station, Okinawa, Japan. Sickcall, Dependent Clinic. Emergency Vehicle Operator and Emergency Medical Technician. 52 ABMC, San Onofre, Camp Pendleton, CA. Physical Exams, Immunizations, Medical Records, Preventive Medicine, Sickcall, and Emergency Vehicle Operator. Experience also includes but not limited to: medical terminology, nursing notes, vital signs, bedside patient care, IV therapy, wound and dressing care, OB/GYN standby, CPR certified, anatomy and physiology, drug interactions.