Assistant Research Practice Manager
The research position for which you are applying is not specific to a clinical research area. Instead, your resume may be shared across the Duke School of Medicine in order to increase the visibility and likelihood of matching eligible candidates with open positions specific to the job title for which you have applied.
Responsible to the CRU Research Practice Manager for the day-to-day operations of the CRU cluster or delegated CRU responsibilities associated with the Site-Based Research group's participation in clinical research studies as an investigative site. Ensure that CRCs and designated research personnel are performing study activities in accordance with Good Clinical Practice (GCP), Duke policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring.
- Serves as assistant to RPM and includes divisional or cluster lead within a CRU with oversight of peers and delegation of project related tasks to others on the study, knowledgeable of various funding sources including industry or federal grants. Ensure that staff are appropriately trained. Participate in assessing the feasibility of new studies with cluster, division, area of disease studied. Ensure that new studies are initiated appropriately and monitor the performance and progress of ongoing studies. Ensure appropriate coordination of IRB submissions, participant recruitment, screening, consent and enrollment, data collection, safety reporting, drug accountability, and record retention.
- Supervise the day-to-day operations of the CRU related to study conduct including IRB submissions and renewals; protocol initiation; patient recruitment, screening, consent, enrollment and follow-up; data collection; safety reporting; drug accountability; study close-out and record retention. Review and supervise activities performed by study coordinators and other research staff involved in study conduct and ensure that activities are performed in accordance with Good Clinical Practice standards, Duke policies and procedures, and applicable regulatory requirements.
- Plan and coordinate staffing needs based on current and future workload requirements.
- Screen, interview and hire study coordinators and other research staff in conjunction with faculty input.
- Coordinate and assign study coordinators and other research staff to individual studies and research related activities.
- Supervise study coordinators and other research staff and perform various personnel actions including, but not limited to, hiring, performance planning and evaluation, scheduling and work assignments, disciplinary action, promotions and transfers.
- Conduct regular meetings with study coordinators and other research staff. Ensure that staff are kept abreast of CRU, departmental and institutional activities, goals, and policies and procedures.
- Plan and coordinate orientation and ongoing training for study coordinators and other research staff. Ensure that current training records and required certifications are maintained.
- Evaluate the feasibility of new studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies. Provide input regarding study selection.
- Ensure appropriate planning and coordination prior to the approval and initiation of new protocols; including the accurate and timely development of the charge assignment grid based on the schedule of events and protocol. Assist in budget/contract negotiations with sponsors.
- Monitor the status of start-up timelines for new studies including IRB approval and contract execution. Monitor the progress of ongoing studies including enrollment, data collection, and close-out
- Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues.
- Review the finances of ongoing trials on a monthly basis in conjunction with the CRU Director, PIs, Financial Manager and study coordinators. Facilitate efforts to address budget-related issues.
- Assist PIs, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.
- Participate in audits conducted by the CTQA group, sponsors, and regulatory authorities. Review and respond to audit reports, and develop and implement corrective action in a timely manner when problems in research practice are identified.
- Conduct CRU QA audits for division or cluster.
- Ensure that the CRU has up-to-date standard operating procedures, that staff are knowledgeable regarding SOPs, and that all activities are conducted in accordance with SOPs.
The Associate RPM will report to the Research Practice Manager.
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Requisition Number: 100005610
Duke Entity: MEDICAL CENTER
Job Code: 1045 ASSIST RESEARCH PRACTICE MANAGER
Job Family Level: 68
Full Time / Part Time: FULL TIME
Regular / Temporary: Regular
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas, an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR RN or Bachelor's degree and 6 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR Master's degree and 4 years of related experience, with at least two years in a research setting. ACRP or SOCRA preferred.
No experience is required beyond what is specified above.
- Excellent written, oral and conversational communication skills to effectively work with diverse groups.
- Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills.
- Excellent time management skills needed to prioritize among many projects both in development and in operation.
- Attention to detail needed to operate accurately and effectively.
- Mastery of Microsoft Office, databases and information systems.
Auto req: ID106711BR