Purpose: Provides a variety of clerical and technical support to the Director of Research Integrity and Compliance, the Institutional Review Board (IRB), the Office of Research Integrity and Compliance (ORIC) and MPHI program and project staff to support the daily activities related to IRB administration. This position requires a broad knowledge of IRB, privacy and MPHI.
Duties and Responsibilities: • Perform clerical and administrative duties under direction of the Director of Research Integrity and Compliance. • Manage the database and communications systems for IRB; analyze and report results. Manage all aspects of the IRB filing system to ensure compliance with federal regulations. • Create, and maintain, Standard Operating Procedures (SOPs) for the Research Integrity Office. • Process IRB applications; including implementing prescreening protocols, recording and maintaining tracking sheets, disseminating applications to reviewers, and implementing review monitoring protocols. • Assist the Director of Research Integrity and Compliance in the renewal of the Federal Wide Assurance (FWA) and Department of Health and Human Services (DHHS) registration; authorization agreements with MDCH, MSU, U of M and other partners as indicated; and CITI training service. • Schedule and assist in preparation for regularly scheduled and ad hoc IRB meetings; including drafting agendas, preparing and disseminating materials, and drafting minutes and notes. Record meetings minutes in compliance with federal regulations. • Act as a liaison and resource to MPHI staff, IRB members, Privacy Officer, Security Officer and the Research Integrity Officer; interpret and relay sensitive and/or confidential information as appropriate; facilitate client contact and respond to questions through various means, including but not limited to: meetings, phone calls, e-mails and the Electronic Project Library (EPL); provide information, or direct client to the appropriate person. • Work with MPHI Finance and Contracts office to submit reimbursement for honorary panel members, track expenses and submit required documentation. • Assist with revision of the key informational documents for the ORIC: Policy and Procedures Manual, IRB Member Guidebook, Electronic Project Library (EPL) User Information and Instructions and others as identified. Track, post and disseminate updated policies, forms and tools. • Coordinate annual audit of projects which are submitted by the Program Office as not research involving human subjects. • Assist with monthly, quarterly, annual and ad-hoc reporting. • Manage the ORIC SharePoint site; including updating postings, adding/removing users, assigning and tracking access authorizations. • Maintain a positive, strong, credible, professional and interpersonal relationship with all parties and represent the best interest of MPHI at all times. • Perform other duties as assigned.
Qualifications/Requirements: Education: Possession of Bachelors’ degree preferred. Experience: A minimum of three to five years experience in office or other business setting, which includes regular contact with a wide variety of people and progressive responsibility for clerical and administrative duties. Must be proficient in word processing and data base management. Important Skills and Characteristics: Strong organization, professional/diplomatic communication skills required. Self- directed and able to set priorities and attend to multiple tasks. Must be comfortable functioning in a fast paced, changing, team environment. Require proficiency in Microsoft Office applications including Word, Excel and Outlook. Basic working knowledge and skills using SharePoint preferred. Work Environment and Physical Requirements: Job may require moderate physical effort including lifting materials and equipment of <35# and involve viewing CRT or VDT screen 50 to 75% of the time. Standard office environment; may require occasional participation in off-site functions. May require valid vehicle operator’s license where needed to perform the duties of the position.
RESPONSIBILITY FOR THE WORK OF OTHERS: No assigned responsibility.
IMPACT ON PROJECTS, SERVICES AND OPERATIONS: This position will ensure the smooth operation of the MPHI IRB process and will provide support to all MPHI employees. This position will allow MPHI’s IRB and ORIC teams to operate efficiently; facilitating compliance with federal regulations, state law and MPHI policy. The Administrative Assistant will represent the best interests of the Institute at all times. Competent performance in this position has a substantial impact on the integrity and professional reputation of MPHI including meeting the needs of MPHI clients in a timely manner, maintaining professional relationships, and enhancing the potential for future contracts with clients. Competence also ensures that current projects will continue to grow and maintain their excellent relationships with clients.
REQUIRED COMMUNICATION Contact Person/Group Frequency Purpose Director of Research Integrity and Compliance Daily Administrative assignments, prioritizing, consultation, information exchange MPHI HIPAA Privacy Officer As needed Coordination of tasks MPHI HIPAA Security Officer As needed Coordination of task MPHI IRB Members Daily Process applications/reviews MPHI clients/staff Daily Forward inquiries, process applications/required MPHI project documentation, respond to requests for information as appropriate EPL IT and Implementation Teams As needed Coordination of tasks, information exchange
“For purposes of employment standards, this classification is “Non Exempt” from the overtime provisions of the Fair Labor Standards Act.”