Manager Academic Research Services

We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities.

Job Description Summary:

The purpose of this position is to provide leadership and management of daily operations for academic research activities and projects in an assigned therapeutic area, regional site, or program / team for OHRI. The Manager, Research is responsible for tactical operational delivery and execution of research studies, projects and/or scholarly activity. He/she is responsible and accountable for planning, coordinating, overseeing, and conducting studies, projects and/or scholarly activity in one or more therapeutic areas, sites, or programs. The Manager, Research of Academic Research is accountable to drive and monitor project related and departmental activities ensuring targets are met according to timelines, budget, and quality expectations. This position will also oversee 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. 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, ensuring OHRI's Academic Research Services team supports investigators with 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 Manager may lead, hire, direct, teach and supervise up to 15 direct reports and research personnel in OHRI ensuring quality and compliance within the department.

Responsibilities And Duties:

Leads the research operations
Independently develop and manage a team for conducting research and/or scholarly activity. Establish and implement organization goals to lead the efforts of the team.
Continuously prioritizes tasks, budgets time, and manages workflow and staff to ensure that all deadlines are met.
Collaborates with principal investigator(s), investigators, trainees, research nurses/coordinators, reg
ulatory coordinators, data coordinators and other staff to assist in developing plans for research projects.
Participate in selection of protocols based on risk matrix and feasibility. Leads feasibility project review.
Advise the senior leadership of new clinical or research trends and information.
Build effective working relationships with executive leadership teams, committees, OhioHealth teams and departments.
Routinely collaborate with counterparts in other departments or other institutions to conduct joint research studies or projects.
Build positive working relationship with pharmaceutical sponsors, academic partners, and other external agencies to ensure positive working interactions on behalf of OhioHealth which may help to foster future collaborations.
Manages the research support team
Provide leadership and mentoring for direct reports and/or regional sites and therapeutic areas.
Serves as a formal and informal leader of teams in a responsible manner that facilities team goals and OHRI goals.
Ensures that new associates have been trained appropriately and meet internal qualifications. Completes 45- and 90-day orientation evaluations.
Monitors team workloads and directs associates to their responsibilities.
May assist with performance evaluations or feedback for research associates involved in other functional research activities.
Plans, organizes, and manages the resources necessary to conduct research and scholarly activity and meet department goals and objectives.
Monitors and evaluates completion of tasks and projects. Provides feedback to team members.
Delegate and assign activities to available resources based on the study / project and expertise of the resources.
Participates and leads meetings to provide initiative updates to research staff. Prepare status reports or other communication to ensure research associates receive updated information.
Develops strategies and makes decisions to meet the needs of the program and uses resources wisely to achieve maximum results.
Continuously seeks ways to utilize available associates effectively and efficiently within resource constraints to meet changing work needs.
Prepare performance evaluations for associates. Provide performance feedback to assigned personnel related to their performance. Routinely assess competencies associated with the position.
Leads departmental activities
Assist the Director, Research regarding specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures.
Work with Director, Research, and leadership to establish and implement strategic goals for the team.
Leads meetings to provide clinical / research / project initiative updates to research staff. Prepare status reports or other communication to ensure research staff receives updated information.
Responsible for developing plans for process improvement efforts and managing outcomes. Oversee and monitor tasks which impact a process or policy change for the department.
Develop and assist in development of Standard Operating Procedures, guidance documents or department standards.
Collect/analyze data and consult with others for the purpose of identifying problems or factors inhibiting the effective accomplishment of goals and objectives.
Develop and recommend recommendations for change and key actions for the purpose of improving efficiency, quality, fiscal accountability, and operations management.
Plan strategies to conduct protocols in compliance with federal regulations.
Conduct or participate in financial review meetings with Principal Investigator, research team and/or finance leadership to identify successful achievement and highlight areas which need improvement.
Review and monitor plans to resolve any financial issues including the action to be taken, person responsible and timeline for completion to document resolution of all identified issues.
Demonstrates initiative to seek information, learn from experience, acquire skills, and make improvements in behavior and career.
Recognizes impact of parts of the system on other parts and the whole; evaluates changes and situations on people, systems, work process and results; applies this thinking to create sound plans, solving problems effectively.
Organize and implement department projects. Oversee and monitor tasks which impact a process or policy change for the department. Act as departmental liaison on internal and external committees.
Mentors team member(s) on academic scholarly activity process. Trains new hires in trial processes and policies.
Develop and implement new training programs and courses for physicians and staff. Serve as a resource for physicians and clinical trials staff with respect to academic research requirements.
Collects and analyzes OHRI financial (with RBS) and performance reporting metrics. Generates reports for team and leadership review. Uses CTMS, EPIC, Workday, and other databases to report project details.
Maintains metrics to track, trend and create/present reports provided to leadership.
Leads Quality and Compliance Efforts
Lead 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 OHRI. Manage the administrative, compliance and training process of the team.
Manage the processes and ensure that scholarly activity and academic research studies are generated, documented, and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations.
Ensure physician, faculty and staff comply with human subjects' protection education and recertification.
Assist in risk assessments and perform analysis, on a routine and ad hoc basis, of research activities. Prepare reports for senior leadership.
Understands clinical, regulatory, and logistical issues unique to conducting research and scholarly activity across therapeutic areas and programs.
Develop and apply policies and procedures necessary to comply with regulatory requirements, internal directives.
Identify and resolve compliance issues.
Trains new physicians, faculty and staff in activities relating to requirements.
Understands and demonstrates knowledge of the regulatory frameworks and legal requirements associated with the planning, conduct and closure of clinical research studies.
Develop and maintain a process flow and associated documents to ensure compliance with OHRI. Acts as liaison for between main campus and regional or affiliate sites in the conduct of clinical trials or projects.
Complies with hospital, departmental policies, procedures, and processes.
Provides training and direction to research associates on regulatory process to promote compliance.
Identifies connections between situations that are not obviously related; identifies underlying patterns, issues and obstacles in complex situations and identifies steps to manage them.
Communication
Leads team meetings with OHRI, PI and study/project teams to review study/project status at a detailed level.
Develops strategies and recommends initiatives / improvements to Director, Research to meet the needs of OHRI and using resources wisely to achieve maximum results.
Oversee and monitor tasks which impact a process or policy change for the department.
Work with research associates to effectively communicate patient process for each trial for the life of the study.
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 appropriate patient care or project detail.
Other
Attends relevant training courses on policy and compliance.
Maintain familiarity with evolving regulatory and compliance context. Stay up to date on new rules and procedures.

Minimum Qualifications:

Master's Degree (Required), Medical Doctor

Additional Job Description:

JOB SUMMARY

The purpose of this position is to provide leadership and management of daily operations for academic research activities and projects in an assigned therapeutic area, regional site, or program / team for OHRI. The Manager, Research is responsible for tactical operational delivery and execution of research studies, projects and/or scholarly activity. He/she is responsible and accountable for planning, coordinating, overseeing, and conducting studies, projects and/or scholarly activity in one or more therapeutic areas, sites, or programs. The Manager, Research of Academic Research is accountable to drive and monitor project related and departmental activities ensuring targets are met according to timelines, budget, and quality expectations. This position will also oversee 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. 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, ensuring OHRI's Academic Research Services team supports investigators with 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 Manager may lead, hire, direct, teach and supervise up to 15 direct reports and research personnel in OHRI ensuring quality and compliance within the department.

MINIMUM QUALIFICATIONS

Master's Degree in scientific or healthcare-related field.

MD or PhD in related field or equivalent experience preferred.

Minimum of 7 years of human subject's research experience required

SPECIALIZED KNOWLEDGE

Knowledge of the translational drug and device development processes along with thorough understanding of GCP and FDA policies and recommendations.

Thorough knowledge of clinical study development including identification of knowledge gaps, generation of hypotheses, trial design, methodology, feasibility assessment, data management, results dissemination

Well-developed organizational skills with attention to details.

Program Management skills and ability to develop program metrics and budgets

Goal-oriented person who takes initiative, self-motivated and a creative problem solver.

Able to review of protocols and apply this knowledge to help operationalize a study. Able to input and evaluate metrics tracking to monitor departmental and associate performance and time expenditures. A working knowledge of Microsoft office and electronic data capture systems

DESIRED ATTRIBUTES

Certified Clinical Research Coordinator or another research certification highly preferred

Broad research management experience: retrospective, QI, cardiovascular; neuroscience; oncology (cooperative and industry); musculoskeletal, etc. Proven experience in all aspects of academic research management as it relates to scholarly activity.

Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize, and manage multiple tasks

Proven track record of leading teams overseeing academic research, IIT development, and general scholarly activity study development.

Proven track record managing research to support institutional accreditation needs.

Demonstrates an extensive level of proficiency in the following competencies or qualifications: Managing or leading/participating in a work team, Effective communication (written and verbal), the ability to effectively and accurately exchange, transmit, receive, and interpret ideas

BEHAVIORAL COMPETENCIES
Leadership Competencies

INFORMATION SECURITY

Maintains confidentiality of log-on password(s) and security of other authentication devices (e.g., key fobs, proximity devices, etc.).

Ensures privacy and security of information entrusted to their care.

Uses company business assets and information resources for management-approved purposes only.

Adheres to all information privacy and security policies, procedures, standards, and guidelines.

Promptly reports information security incidents to the OhioHealth Information

RESPONSIBILITIES AND DUTIES

Leads the research operations

Independently develop and manage a team for conducting research and/or scholarly activity. Establish and implement organization goals to lead the efforts of the team.

Continuously prioritizes tasks, budgets time, and manages workflow and staff to ensure that all deadlines are met.

Collaborates with principal investigator(s), investigators, trainees, research nurses/coordinators, reg

ulatory coordinators, data coordinators and other staff to assist in developing plans for research projects.

Participate in selection of protocols based on risk matrix and feasibility. Leads feasibility project review.

Advise the senior leadership of new clinical or research trends and information.

Build effective working relationships with executive leadership teams, committees, OhioHealth teams and departments.

Routinely collaborate with counterparts in other departments or other institutions to conduct joint research studies or projects.

Build positive working relationship with pharmaceutical sponsors, academic partners, and other external agencies to ensure positive working interactions on behalf of OhioHealth which may help to foster future collaborations.

Manages the research support team

Provide leadership and mentoring for direct reports and/or regional sites and therapeutic areas.

Serves as a formal and informal leader of teams in a responsible manner that facilities team goals and OHRI goals.

Ensures that new associates have been trained appropriately and meet internal qualifications. Completes 45- and 90-day orientation evaluations.

Monitors team workloads and directs associates to their responsibilities.

May assist with performance evaluations or feedback for research associates involved in other functional research activities.

Plans, organizes, and manages the resources necessary to conduct research and scholarly activity and meet department goals and objectives.

Monitors and evaluates completion of tasks and projects. Provides feedback to team members.

Delegate and assign activities to available resources based on the study / project and expertise of the resources.

Participates and leads meetings to provide initiative updates to research staff. Prepare status reports or other communication to ensure research associates receive updated information.

Develops strategies and makes decisions to meet the needs of the program and uses resources wisely to achieve maximum results.

Continuously seeks ways to utilize available associates effectively and efficiently within resource constraints to meet changing work needs.

Prepare performance evaluations for associates. Provide performance feedback to assigned personnel related to their performance. Routinely assess competencies associated with the position.

Leads departmental activities

Assist the Director, Research regarding specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures.

Work with Director, Research, and leadership to establish and implement strategic goals for the team.

Leads meetings to provide clinical / research / project initiative updates to research staff. Prepare status reports or other communication to ensure research staff receives updated information.

Responsible for developing plans for process improvement efforts and managing outcomes. Oversee and monitor tasks which impact a process or policy change for the department.

Develop and assist in development of Standard Operating Procedures, guidance documents or department standards.

Collect/analyze data and consult with others for the purpose of identifying problems or factors inhibiting the effective accomplishment of goals and objectives.

Develop and recommend recommendations for change and key actions for the purpose of improving efficiency, quality, fiscal accountability, and operations management.

Plan strategies to conduct protocols in compliance with federal regulations.

Conduct or participate in financial review meetings with Principal Investigator, research team and/or finance leadership to identify successful achievement and highlight areas which need improvement.

Review and monitor plans to resolve any financial issues including the action to be taken, person responsible and timeline for completion to document resolution of all identified issues.

Demonstrates initiative to seek information, learn from experience, acquire skills, and make improvements in behavior and career.

Recognizes impact of parts of the system on other parts and the whole; evaluates changes and situations on people, systems, work process and results; applies this thinking to create sound plans, solving problems effectively.

Organize and implement department projects. Oversee and monitor tasks which impact a process or policy change for the department. Act as departmental liaison on internal and external committees.

Mentors team member(s) on academic scholarly activity process. Trains new hires in trial processes and policies.

Develop and implement new training programs and courses for physicians and staff. Serve as a resource for physicians and clinical trials staff with respect to academic research requirements.

Collects and analyzes OHRI financial (with RBS) and performance reporting metrics. Generates reports for team and leadership review. Uses CTMS, EPIC, Workday, and other databases to report project details.

Maintains metrics to track, trend and create/present reports provided to leadership.

Leads Quality and Compliance Efforts

Lead 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 OHRI. Manage the administrative, compliance and training process of the team.

Manage the processes and ensure that scholarly activity and academic research studies are generated, documented, and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations.

Ensure physician, faculty and staff comply with human subjects' protection education and recertification.

Assist in risk assessments and perform analysis, on a routine and ad hoc basis, of research activities. Prepare reports for senior leadership.

Understands clinical, regulatory, and logistical issues unique to conducting research and scholarly activity across therapeutic areas and programs.

Develop and apply policies and procedures necessary to comply with regulatory requirements, internal directives.

Identify and resolve compliance issues.

Trains new physicians, faculty and staff in activities relating to requirements.

Understands and demonstrates knowledge of the regulatory frameworks and legal requirements associated with the planning, conduct and closure of clinical research studies.

Develop and maintain a process flow and associated documents to ensure compliance with OHRI. Acts as liaison for between main campus and regional or affiliate sites in the conduct of clinical trials or projects.

Complies with hospital, departmental policies, procedures, and processes.

Provides training and direction to research associates on regulatory process to promote compliance.

Identifies connections between situations that are not obviously related; identifies underlying patterns, issues and obstacles in complex situations and identifies steps to manage them.

Communication

Leads team meetings with OHRI, PI and study/project teams to review study/project status at a detailed level.

Develops strategies and recommends initiatives / improvements to Director, Research to meet the needs of OHRI and using resources wisely to achieve maximum results.

Oversee and monitor tasks which impact a process or policy change for the department.

Work with research associates to effectively communicate patient process for each trial for the life of the study.

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 appropriate patient care or project detail.

Other

Attends relevant training courses on policy and compliance.

Maintain familiarity with evolving regulatory and compliance context. Stay up to date on new rules and procedures.

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