ASSIST RESEARCH PRACTICE MANAGER

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

ASSIST RESEARCH PRACTICE MANAGER
Regulatory Services

The Assistant Research Practice Manager will report to the Manager for Human Subjects Protections/Research Practice Manager and share responsibility for the day-to-day operations of the CRU related to study conduct including IRB submissions and renewals. # Accountable for performing activities in accordancewith all institutional standards for study conduct, and more specifically those relating to clinical research, providing information to the Duke Office of Clinical Research, as needed. # Manage the day-to-day operations of the DCRI CRU related to study conduct including IRB submissions and renewals. Shares responsibility with DCRI#s RPM as liaison with the Duke University Health System Institutional Review Board (DUHS IRB). Consults with the IRB regarding DCRI protocols and study activities and recommends to the IRB an appropriate course of action for each. # Authorize DCRI IRB submissions as a Designee of the Director of the Duke Clinical Research Institute. Consults with campus stakeholders re: DCRI protocols to determine appropriate assignment of organizational responsibility and negotiates with stakeholders when ownership issues arise. Consults with DCRI Therapeutic Area Leaders who perform scientific review of projects to ensure adequate study oversight. # Monitor the status of timelines and key milestones for clinical research studies conducted within the DCRI including contract execution, IRB approval, enrollment, etc. Activities supervised include: Submit IRB protocols, amendments and renewals; Initiate studies; Communicate research issues within and outside the DCRI CRU; Close out studies and ensure retention of records per Duke and sponsor policy; Ensure that research activities are performed in accordance with Good Clinical Practice standards, Duke policies and procedures, and applicable regulatory requirements; Monitor the progress of start-up timelines for new studies, including IRB approval, contract negotiations; Monitor the progress of ongoing studies including enrollment, data collection, and close-out, while providing regular updates to the CRU Director and other related research activities as determined by the RPM in day to day operations. # Approves Research Data Security Plans submitted through the electronic application system (eIRB). # Serve as an expert resource to PIs, CRCs, other research staff and outside agencies with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues. Assist PIs and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions. # Ensure that staff are knowledgeable regarding SOPs,and that all activities are conducted in accordance with SOPs; Coordinate orientation to eIRB and ongoing training for research staff. # Participate in audits conducted of CRU studies by both internal and external authorities. Review and respond to audit reports, and develop and implement corrective action in a timely manner when problems are identified. # Work with the RPM and the CRU Financial Practice Manager (FPM) to: Evaluate the feasibility of new studies including staffing requirements, clinical and logistical considerations, and competing studies; provide input into financial feasibility of each new study by providing study plan details to FPM for the development of an internal cost summary; review and evaluate the charge assignment grid based on the schedule of events and protocol; provide training and consultative advice to PIs and staff in the negotiation of study budgets & payment terms with sponsors. # Liaises with the Duke School of Medicine#s Research Integrity Office for the assessment of potential conflicts of interest for site investigators. Assessing whether collection of COI reporting forms from site investigators are required in studies where the drugs or devices are ones for which FDA marketing exclusivity is no longer relevant (i.e., the therapies are generic). Resource for project teams in managing the evaluation of potential conflicts of interest. # Liaises with the Duke Office of Export Control to ensure DCRI compliance with Duke University policies and procedures related to United States (U.S.) export control laws. # Develops and implements IRB submissions user guides, tools and processes that improve compliance with human subjects protections policies and procedures and streamlines processes. # Responsible for evaluating DCRI IRB protocol submissions prior to submission to the DUHS IRB to ensure that information is complete, accurate, and complies with applicable regulations, guidance and standards. # Provides guidance and support to Principal Investigators and project teams during the IRB submission and approval process. Assist Principal Investigators and project teams by facilitating resolution of queries from the DUHS IRB. # Develops, coordinates, and implements regulatory strategies essential to the successful management of clinical research projects. Advises DCRI project teams of regulatory risks that could negatively affect timelines and identifies solutions. Consults with study personnel to ensure they are aware of and understand applicable regulations and guidance. # Reviews protocols and informed consent templates for compliance to FDA, ICH, and DHHS (NIH and HIPAA) requirements. Gives input for development and modification of protocols. Recommends changes to protocols, as appropriate. # Supports efforts to improve compliance with human subjects# protections policies and procedures, with a focus on continuous improvement. Provides regulatory education outreach through creation and updates of FAQs and other resources on the Intranet and through training presentations. # Attends DCRI Business Development OPT meetings to assist in bid review for Regulatory Services functions. At the request of the Assistant Director, Regulatory Services, represents DCRI in interactions with external organizations,such as industry sponsors and funding agencies. # Reviews and recommends revisions to Regulatory Services SOPs and other DCRI SOPs, with the intention to improve and streamline processes. Identifies need for, and composes drafts of, new SOPs and policies. # Provides other regulatory services, as requested, and with minimal supervision.

Requisition Number
401233326

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1045 ASSIST RESEARCH PRACTICE MANAGER

Job Family Level
68

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. 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.

Education

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.

Experience

No experience is required beyond what is specified above.

Auto req ID

87516BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

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