ASSIST RESEARCH PRACTICE MANAGER

Occupational Summary

Responsible to the Research Practice Manager (RPM) for oversight of study conduct for research studies within the assigned division(s) or cluster(s). Assist the RPM in the day to day management of CRU operations and people. Ensure that clinical research professionals and investigators are appropriately trained and performing activities in accordance with good clinical practice, CRU standards, institutional policy, and regulatory requirements. Assist in providing operational and study conduct metrics/reports to RPM.

Work Performed

Management and Institutional

· Responsibility Screen, interview, and hire clinical research professionals with faculty and RPM input.

· Collaborate with Duke Office of Clinical Research (DOCR) and other School of Medicine (SOM) resources to conduct onboarding, training, and professional guidance for clinical research professionals, including navigation through the Tier Advancement process.

· Assist with staff effort distribution, for the assigned divisions or clusters, to ensure that staff are appropriately assigned studies based on volume and individual staff competency.

· Conduct annual performance evaluations and performance improvement plans with staff; consulting with Human Resource Manager and RPM if needed.

· For assigned division(s) or cluster(s), oversee the operations of studies and provide regular updates to the RPM as needed. This may include study start up, enrollment, recruitment, closeout, continuing renewals, etc.

· Provide research metrics to RPM in order to advise on high level decisions.

· Serve as an expert resource to assigned division (s) or cluster(s) with regard to study conduct and is knowledgeable about other resources at Duke.

· Continuously identify methods and work with the RPM to improve CRU and institutional procedures and policies.

Research Operations

· Supervise and provide guidance on research operations for the studies within the assigned division(s) or cluster(s). This includes: regulatory and institutional policies and processes, screening, recruitment and retention, study monitoring, audit visits, participant and study level documentation, study visits, SOPs, specimen management, IND/IDE/ITP documentation, investigational product, and contracts and agreements.

· Ensure that key personnel are properly trained and document training according to institutional and regulatory policies in a timely fashion.

· Assist clinical research professionals in the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

· Should be knowledgeable about SOM resources available to teams for assistance.

· Conduct internal quality assurance audits of specific studies and assists in preparation for external audits.

· Review and respond to audit reports, and develop and implement corrective action plans in a timely manner when problems are identified.

· Lead multidisciplinary team meetings by establishing attendance lists, agendas, creating action items, and following up on action items.

Safety and Ethics

· Monitor compliance with institutional requirements and provide guidance to assigned division(s) or cluster(s), at Duke pertaining to: developing and submitting documentation and information for IRB review, preparing and submitting documents needed for regulatory and safety reporting to sponsors and other agencies, identifying and documenting adverse event information, conducting and documenting consent, and developing consent documents and processes.

Data

· Monitor compliance with institutional requirements and provide guidance to assigned division(s) or cluster(s) at Duke pertaining to quality data collection and capture, data flow plans, data security and provenance, and data quality assurance.

· Guides assigned division(s) or cluster(s) to institutional resources as necessary for study compliance with data processes and policies (e.g., ISO, IRB).

· Performs data audits on specific studies and provides corrective action as needed.

· Assists with and provides guidance on the implementation of new technologies and data capture requirements across the CRU.

Scientific Concepts

· Assist RPM with ensuring appropriate documentation of scientific review processes, including decisions made by scientific reviewers/review committees.

Site and Study Management

· Collaborate with CRU Financial Practice Manager (FPM) and RPM to evaluate the feasibility of new studies.

· Provide input and information to assist the RPM in making decisions regarding study selection.

· Work with financial staff in developing and negotiating budgets with sponsors.

· Should be knowledgeable about SOM resources available to teams for assistance.

· Review the finances of ongoing trials on a regular basis in collaboration with the CRU Director, RPM, PIs, Financial Manager and other clinical research professionals.

· Facilitate efforts to address budget related issues.

· Serve as an expert resource to clinical research professionals and outside agencies with regard to study specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory concerns.

· Ensure that studies within the assigned division(s) or cluster(s) are conducted in compliance with institutional requirements and policies.

· Acts as the primary contact during study startup and intervenes when study teams have a conflict with sponsors and/or CROs.

Leadership and Professionalism

· Keep current with research updates and oversee implementation of new policies and regulations among staff members.

· Evaluate and implement professional development and/or training programs offered through DOCR (e.g., Research Professionals Network (RPN), Research Wednesdays) to encourage staff retention, continuous improvement, and development.

· Contribute to and represent the institution in internal and external groups related to research or therapeutic area (e.g., institutional initiatives or committees).

· Uses advanced subject matter expertise in clinical research activities to solve complex problems across assigned division(s) or cluster(s).

· Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

· Create a team environment with a culture that fosters communication.

· Communicate effectively across the assigned division(s) or cluster(s) about new policies, regulatory updates, and institutional SOP changes.

· Develop and implement solutions within assigned division(s) or cluster (s) to improve the research process.

· Demonstrate resilience, leadership, and actively facilitate change within CRU.

Required Qualifications at this Level

Education/Training: Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred

Experience: Work requires a minimum of six years of related experience, with at least four years in a research setting. A Master's degree may substitute for two years of related experience

Job Skill Requirements: Experience in clinical research working with pediatric patients is preferred, but not required.

Minimum Qualifications

Education

Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.

Experience

Work requires a minimum of six years of related experience, with at least four years in a research setting. A Master's degree may substitute for two years of related experience.

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