Clinical Research Manager

Clinical Research Manager 1 (M1) manages a team of 4-7 clinical research staff engaged in scientific inquiry and creative expression within the realm of health, wellbeing, disease, and prevention. The role involves overseeing the daily activities of technical, administrative, support, or clinical staff, ensuring the training and orientation of employees, and most often reports to a Manager (M2). Operating primarily within a single work area, this innovative leader administers policies and executes procedures in alignment with departmental priorities. With a focus on short-term goal achievement and team performance, responsibilities include setting direction, deploying resources, conducting performance management, reviewing pay, and making employment decisions. Utilizing public health acumen and research industry knowledge, the Clinical Research Manager employs their expertise to educate and support the research team, ensuring the achievement of departmental research goals, directly and indirectly. Interactions primarily occur with peers and subordinates to share information and resolve routine matters, with an emphasis on explaining policies, standards, and processes. The role contributes significantly to the advancement of clinical research endeavors, facilitating the discovery of new methods for detecting, diagnosing, treating, and preventing diseases through rigorous scientific investigation and scholarly output. The Clinical Research Manager serves as primary resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the Department of Physical Medicine and Rehabilitation in the Ohio State College of Medicine and plans, implements amp; oversees daily conduct of protocol activities; serves as primary resource for clinical research coordinators, clinical research assistants, and federal work study students in resolving issues related to active protocols; monitors amp; ensures compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state amp; industry sponsor regulations; participates in planning and preparing for external compliance, quality assurance amp; control reviews; participates in development of new research protocols and contributes to planning of goals to meet study requirements; participates in the design and development of novel research projects utilizing various advanced study designs in qualitative and quantitative fields; participates in the development and submission of research grants; works closely with principal investigators upon awarding of new protocols and recommends team assignments; prepares publications, abstracts, and presentations and/or assists with the preparation and submission of publications, research reports, abstracts, and presentations for the dissemination of research knowledge.

Essential Duties

35%: Plans, implements amp; oversees daily conduct of protocol activities; determines, coordinates amp; assigns clinical research tasks to research team; oversees, evaluates and revises processes to identify, recruit and enroll patients into clinical studies; ensures informed consent authorization is obtained amp; administered in compliance to regulatory amp; sponsor requirements; ensures initial and follow-up data collection are appropriately scheduled and fulfilled for participants; calculates scoring of administered diagnostic, psychological or behavioral testing or questionnaires; assesses risk to benefit ratios; coordinates and documents care of patients; participates in evaluating patients for compliance related to protocol; monitors patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, amp; provide appropriate level of care; documents and notifies PI, facilitates team meetings and disseminates information; serves as liaison between investigators and staff at other sites.

15%: Participates in collecting, extracting, coding, and analyzing clinical research data; reviews research data to ensure validity and discover inconsistent or inaccurate data; assists with development of clinical research study database; compiles and enters clinical research data into study database; generates reports.

15%: Participates in development of new research protocols and contributes to planning of goals to meet study requirements; assists Principal Investigator with preparation and submission of national and local grant submissions to secure continued and additional funding of clinical research projects; works closely with principal investigators upon awarding of new protocols and recommends team assignments; assists with planning and development of clinical study processes; participates in workshops, training programs, and independent study to develop and increase research expertise and/or to develop general knowledge related to newly identified research priorities relevant to TBI Team priorities; completes special projects as required.

10% Develops and monitors project budgets and expenditures.

10%: Participates in interviewing and selection of clinical research staff; trains, mentors and supervises staff, including federal work study and intern placements, in alignment with departmental priorities and usually in coordination with a Manager (M2). Administers policies, executes procedures, manages performance, contributes to team discipline, and approves timesheets; attends departmental meetings. attends institutional, local, state, and national professional and scientific conferences to continue professional development and disseminate research results; completes special projects as required.

15%: Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research; supports activities, monitors amp; ensures compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; prepares and participates in study monitoring activities; participates in planning, organizing and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; actively participates in internal quality assurance audits; completes case report forms.