Research Regulatory Coordinator

Rogers Behavioral Health•Oconomowoc, WI

17h•Onsite

About The Position

The Research Regulatory Coordinator is responsible for ensuring that the Rogers Research Center complies with institutional, state and federal regulations and guidance in the conduct of human subjects research. The Coordinator maintains the relationship with the external Institutional Review Board (IRB) and other regulatory bodies. The Coordinator ensures that active research proposals are thoroughly reviewed by the appropriate authorities, that patient consent and privacy is strictly respected and that research risks are mitigated or managed appropriately by investigators. The Coordinator is responsible for collecting and preparing study documentation for administrative and regulatory review and ensuring that investigator documentation is complete. The Coordinator is knowledgeable about federal guidelines and organizational policies regarding human subjects research and institutional review board (IRB) procedures, makes recommendations for exempt, expedited or full review requirements, and serves as a subject matter expert for investigators on the policies and procedures governing research conduct at Rogers, as well as taking the lead on developing and maintaining relevant policies and procedures.

Requirements

Bachelor's degree required.
Three (3) years of work experience in a clinical research setting.
Strong interpersonal skills necessary to interact and communicate effectively with Principal Investigators, and sponsors, system leadership, and to maintain a variety of internal and external contacts.
Possess an excellent verbal and written command of the English language.
Organizational skills: Good problem-solving capability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations.
Demonstrated knowledge of Microsoft Office, Excel, Adobe Acrobat, internet, and other computer software is required.
Strong interpersonal and professional communication skills needed, due to interaction with professional staff and patients.
Detail oriented, able to demonstrate attention to detail, organization of files and documents, both digital and hard copy, and development of and adherence to complex processes.
Must be able to work independently and complete assignments within specified timeframes.
Must be highly proficient in verbal and written communication skills.
Verbal and hearing ability required to interact with patients and employees.
Numerical ability required to maintain records and operate computer.
Be able to plan, control and direct all aspects of employee relations.
Logical thinking and discretion required to make decisions in initiating and implementing policies and procedures and standards.
Must be able to read and communicate through written, verbal and auditory skills and abilities.
Be physically/mentally able to perform job duties as verified by a physical exam by a licensed physician, per post-employment physical.

Responsibilities

Serve as the main point of contact with the External IRB and support coordination of external IRB related communications and submissions.
Facilitate the research readiness review process ensuring that research submissions meet all necessary criteria prior to submission to the IRB.
Document all IRB related submissions and documents with consistent, timely and thorough preparation.
Track IRB-related invoices and review and process payments in accordance with institutional procedures and payment terms.
Maintain research related dashboards and tracking systems.
Manage the Principal Investigator (PI) application and approval process, including collecting training and credentialing documentation and sending approval letters.
With the Research Center data team and in collaboration with the Rogers data analytics team, facilitate and track research data requests.
Other Clinical Research duties as assigned, including but not limited to maintaining the training and certifications required to serve as a patient-facing study assistant or coordinator, as needed.
Serve as subject matter expert to investigators and collaborators for access and use of Rogers patient data for research purposes, including developing, refining, leading or facilitating business processes that govern this practice.