Lead Academic Research Specialist

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Job Description Summary:

This position is responsible for facilitating current and future research, quality improvement (QI), and other scholarly activity projects for OhioHealth physicians, associates, trainees, and other members of research teams. As Lead Senior Consultant, Academic Research, this position will assist the Manager and Director of Academic Research Services (ARS) with administrative and other duties related to the Senior Consultant, Academic Research role. The Lead Senior Consultant will assist the Manager in making work assignments for the team of Senior Consultants, Academic Research by considering workload, expertise, therapeutic area and program needs. This position will also facilitate the development and execution of projects, play a key role in educating associates on best practices for research and QI, and work in a multidisciplinary manner to achieve research goals that are strategically aligned with OHRI and OhioHealth. Clinical research activities and projects will be in an assigned therapeutic area(s), regional site, or program/team for OHRI. Other responsibilities include, but are not limited to, literature reviews, study development, assisting with funding applications, dissemination of results in the form of posters, presentations and manuscripts, participant contact and enrollment, and ensuring compliance with state, federal, local, and organizational regulations. The Lead Senior Consultant, Academic Research is responsible for coordinating activities within the study team and representing the study team and OHRI through interactions with internal and external partners such as the Office of Human Subjects Protections, the Office of Research Compliance, Medical Education departments, care site administrators, academic partners, and other stakeholders. This position is also responsible for leading the annual OhioHealth Research Symposium, administration of ClinicalTrials.gov registration and reporting requirements for OhioHealth studies, and mentoring and onboarding new ARS staff.

Responsibilities And Duties:

30%

Develop and Oversee Research, QI, and Scholarly Projects. Collaborate with OhioHealth principal investigators PIs , physicians, allied health groups, clinical staff, research nurses/coordinators, regulatory coordinators, trainees, students, data coordinators and other staff, and external stakeholders to facilitate project development, approval, and execution. Follow OHRI and OhioHealth standard operating procedures and policies. Incorporate best practices for conduct of research activities into daily activities and research protocols. Effectively coordinate project development and implementation by establishing project timelines and deliverables, and ensuring that team meetings take place as needed. Continuously prioritize tasks, budget time and handle workflow to ensure that all deadlines are met. Provide information for the study feasibility review committee. Conduct initial discussions with PI and/or research team members for project development. Prepare detailed research protocols and/or project-related documents using principles of best practices for conduct of research or QI. Assist with submission of documents to the Institutional Review Board, QI Determination Committee, or other entity as needed. Work with research team to revise and resubmit research documents based on feedback from Scientific Review Committee, IRB, and other entity as needed. Assist Regulatory team in preparation of protocol amendments. Assist with protocol-specific training for research team. Advise leadership and Academic Team of new clinical or research trends and information. Maintain familiarity with the clinical literature related to assigned therapeutic areas. Build effective working relationships with leadership teams, committees, OhioHealth teams and departments. Routinely collaborate with counterparts in other departments or other institutions on joint research studies or projects. Build positive working relationships with sponsors, academic partners, and other external agencies to ensure positive working interactions on behalf of OhioHealth. Work closely with other OHRI Regulatory, Clinical Operations, and Research Business Services teams. Mentor Research Assistants in understanding concepts of clinical research and quality improvement. Work with Manager, Academic Research Services to make work assignments for team of Senior Consultants, Academic Research, considering work load, expertise, therapeutic area and program needs. Mentor and onboard new ARS staff.

20%

Maintain Research Projects. Assist with records management for assigned studies to maintain compliance with Institutional Review Board and Office of Human Subjects Protection. Monitor progress of research studies and problem solve as appropriate. Provide feedback to team members. Work with ARS Manager to enlist other available resources based on the study/project and expertise of the resources. Participate in meetings to provide project and initiative updates to OHRI staff and research teams. Prepare status reports or other communication to ensure research associates receive updated information. Develop strategies to meet the needs of the program and use resources wisely to achieve maximum results. . Continuously seek ways to effectively and efficiently utilize available resources to meet changing work needs. Be proficient in use of REDCap, CTMS, IRBNet, CareConnect, ResearchMatch and other platforms to develop and maintain study records and research data. Serve as a resource to other Research Specialists on best practices for maintaining research projects. . Represent the Senior Consultant, Academic Research group in process improvement efforts with other OHRI and OhioHealth teams.

20%

Scientific and Research Communication . Assist study teams in developing dissemination plans, including posters, presentations, and manuscript submissions. Help investigators select optimal publication format and venue. Provide assistance with preparation, editing, and revision of various forms of research/QI dissemination as appropriate . Work with OHRI Sponsored Programs Office on identifying funding opportunities and helping to frame, design, and write funding applications as requested. Teach investigators, associates and trainees about the research process and regulatory requirements at OhioHealth. . Participate in the Summer Research Externship Program and other initiatives by providing research and scientific expertise, didactic lectures, and mentorship. Continuously assess communications for clarity, accuracy, professionalism, and conciseness, keeping in mind the intended audience and skill level s . Seek feedback on scientific communication delivered in didactic, small group, written, and team-based formats. Lead research education efforts for residents, other learners, PIs and associates, using principles of adult learning and engaging the audience based on level of experience and need. Participate in service line research meetings, Value Development Review Committee meetings, Clinical Guidance Council meetings, and other meetings as assigned. Identify resources to help team evaluate and improve scientific communication and assist with those efforts.

10%

Compliance. Assist with compliance efforts on behalf of OHRI aligned with the Quality Assurance Department, the Office of Human Subjects Protections, and the Office of Research Compliance. Assume responsibility for audit preparedness activities for assigned studies/projects. Assist with the administrative, compliance and training process of trainees and other research associates as assigned. . Ensure that projects are generated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. Assist OHRI Regulatory team to ensure physician, faculty and staff comply with human subjects protection education and recertification. . Assist in risk assessments of research activities. Communicate concerns to OHRI leadership in a timely manner. Understand and demonstrate knowledge of the regulatory frameworks and legal requirements associated with the planning, conduct and closure of clinical research studies. Comply with hospital, departmental policies, procedures and processes. . Assist PIs in maintaining compliance with ClinicalTrials.gov registration and reporting. Oversee compliance with Clinical Trials.gov registration and reporting.

10%

Communication. Participate in team meetings with OHRI, PI and study/project teams to review study/project status at a detailed level. Lead meetings as appropriate. Recommend initiatives and process improvements to Director, Academic Research Services to meet the needs of OHRI and use resources wisely to achieve maximum results. Work with research teams and associates to effectively communicate study status, areas of risk, review of milestones, and other relevant information. Advise, communicate and reinforce standard practices, contractual or regulations to following regarding research study or project including patient care, coverage analysis, cost accounting, patient costs, budget, etc. Work with stakeholders to review and monitor compliance as appropriate. Maintain a professional demeanor in all communications, regardless of medium email, telephone, in-person . Demonstrate initiative to seek information, learn from experience, acquire skills and make improvements in behavior and career. Model effective communication and problem-solving skills for other members of the team.

10%

Other. Attend relevant training courses on research process, study design, QI, project management, and responsible conduct of research. May assist with performance evaluations or feedback for research associates involved in other functional research activities. Lead the annual Research Symposium. . Participate and contribute to initiatives and efforts such as the OhioHealth Research Compendium.The major duties, responsibilities and essential functions listed above are not intended to be all-inclusive of the duties, responsibilities and essential functions to be performed by employees in this job. Employee is expected to all perform other duties as requested by supervisor.

Minimum Qualifications:

Master's Degree (Required)CCRP - Certified Clinical Research Coordinator - The Society of Clinical Research Associates (SOCRA)

Additional Job Description:

Thorough knowledge of clinical study development including identification of knowledge gaps, generation of hypotheses, trial design, methodology, feasibility assessment, data management, results dissemination.Understanding of GCP and FDA policies and recommendations.Working knowledge of quality improvement processes.Well-developed organizational skills with attention to details. Documented people skills and professional communication ability.Goal-oriented person who takes initiative, is self-motivated and a creative problem solver.A working knowledge of Microsoft office, electronic data capture systems, and ClinicalTrials.gov is needed.- Clinical research experience- Project management skills- Proven experience in all aspects of clinical trial management- Knowledge of OhioHealth data systems, experience working with a variety of IRBs preferred

Work Shift:

Day

Scheduled Weekly Hours :

40

Department

Academic Research

Join us!

... if your passion is to work in a caring environment

... if you believe that learning is a life-long process

... if you strive for excellence and want to be among the best in the healthcare industry

Equal Employment Opportunity

OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment