Research Regulatory Consultant

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Job Description Summary:

The Consultant, Regulatory will provide regulatory management oversight for pre-award and post-award activities for clinical trials and research projects to provide system-wide support of OhioHealth research activities in accordance with Good Clinical Practices (GCP) Activities include a variety of complex and varied regulatory and administrative support functions such as analyzing protocols, developing informed consent documents, developing and maintaining study regulatory documents, establishing and maintaining comprehensive regulatory recordkeeping systems, preparing study amendments, and maintaining regulatory oversight functions across OhioHealth research sites. The person in this position provides compliance oversight and guidance and communicates and interprets agency policies and requirements for research personnel. This includes acting to improve internal processes when possible, follow-up and management of research files.

Responsibilities And Duties:

• 30%
• Project coordination works with research nurses and physicians to implement study procedures; consult with principal investigator in project decision-making; assigns work to project staff; orients and instructs investigators and staff on data collection and project record-keeping procedures. . Ensures investigators have undergone RMH-required education on research regulations. Maintains and stores confidential data collection forms, proposals, and final reports in accordance with the hospital's research policies. Acts as a Liaison with the trial sponsor during the regulatory submission process, collects, organizes, logs, files and transmits all required site & investigator documents. Initiates new research protocol regulatory files in compliance with department SOPs and the Federal Code of Regulations. Acts as a resource to clinical research staff on research regulatory concerns. May be asked to internally audit projects to ensures studies are conducted in accordance with federal regulations related to human subjects’ research. Prepares, maintains, and updates computerized database pertaining to research patients.

• 20%
• Project Planning facilitates multidisciplinary research team; assesses feasibility of research projects; designs data collection processes. Reviews project proposals for completeness and appropriate formatting. Conducts initial review and dissemination of research protocols, protocol revisions, protocol amendments and obtains opinions from others, when appropriate.

• 50%
• Liaison with Institutional Review Board on ethical matters regarding hospital-sponsored human subjects’ research; responds to IRB correspondence and determination letters. Prepare proposals applications and submissions to the appropriate institutional review board . . Responds to requests for information which originate from other hospital departments, investigators and outside sponsors concerning status of IRB approval.

• Quality and Compliance
• Assists in audit preparedness activities for OHRI.
• Assists with monitoring visits on site and remotely and is available during visits for corrections, questions, etc.
• Maintains study records according to sponsor and/or regulations.
• Keep records in a secure location.

• Reporting
• Assist in the development of reporting metrics.
• Generates reports and reviews to ensure accuracy.
• Provide ad hoc reports.

• Communication
• Demonstrates effective communications skills.
• Communicates information in a timely and accurate manner.
• Functions as a liaison with sponsor and investigator regarding the preparation, execution, and completion of studies.
• Adapts communication skills in response to various situations including those related to differences in culture, age, education, and other communication barriers.
• Uses various media forms to maximize communication success.
• Demonstrates teamwork characteristics.
• Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects.
• Participates in meetings with OHRI, PI and clinical teams to review study status at a detailed level.
• Work with research staff to effectively communicate compliant process for each trial for the life of the study.
• Advise, communicate, and reinforce standard practices, regulations to follow regarding research study participation.

• Other
• Attends relevant training courses on policy and compliance.
• Ensures assigned training is complete and meets internal qualifications.
• Responsible for completing all necessary training for their position.
• Maintain familiarity with evolving regulatory and compliance context.
• Other duties as assigned.

Minimum Qualifications:

Bachelor's Degree (Required)

Additional Job Description:

• •Field of Study: Biological sciences, Administration, or related field
• •OR Associate's Degree with 3 to 4 years clinical research experience
• •Years of experience: 2 years of experience in hospital/clinical or administrative setting.

• SPECIALIZED KNOWLEDGE
• Field of Study: Biological science, Administration or related field or an Field of Study: a related field, 3 -4 years of clinical research Experience and possess Certification as a clinical research coordinator (e. g. , ACRP or SoCRA) or currently eligible to obtain the Certification . Medical terminology, proficiency in database, spreadsheet and word processing software. 4 years Experience in hospital/clinical setting, work Experience with physician contact.

• DESIRED ATTRIBUTES
• Certified clinical research coordinator (e. g. , ACRP, SoCRA) knowledge of federal regulations on human subject research, IRB regulations 1-2 years in research setting, experience with budgeting

RESPONSIBILITIES AND DUTIES

• 30%
• Project coordination works with research nurses and physicians to implement study procedures; consult with principal investigator in project decision-making; assigns work to project staff; orients and instructs investigators and staff on data collection and project record-keeping procedures. . Ensures investigators have undergone RMH-required education on research regulations. Maintains and stores confidential data collection forms, proposals and final reports in accordance with the hospitals research policies. . Acts as a Liaison with the trial sponsor during the regulatory submission process, collects, organizes, logs, files and transmits all required site & investigator documents. Initiates new research protocol regulatory files in compliance with department SOPs and the Federal Code of Regulations. Acts as a resource to clinical research staff on research regulatory concerns. May be asked to internally audit projects to ensures studies are conducted in accordance with federal regulations related to human subjects research. Prepares, maintains and updates computerized database pertaining to research patients. May assist in coordinating accounts payable/receivable for clinical trials involving pharmaceutical companies and consortiums. May act as liaison between accounting and finance.
• 20%
• Project Planning facilitates multidisciplinary research team; assesses feasibility of research projects; designs data collection processes. Reviews project proposals for completeness and appropriate formatting. Conducts initial review and dissemination of research protocols, protocol revisions, protocol amendments and obtains opinions from others, when appropriate.
• 50%
• Liaison with Institutional Review Board on ethical matters regarding hospital-sponsored human subjects research; responds to IRB correspondence and determination letters. Prepare proposals applications and submissions to the appro