ASSIST RESEARCH PRACTICE MANAGER

Location
Durham, NC
Posted
Jun 20, 2017
Institution Type
Four-Year Institution

diversity employer



ASSIST RESEARCH PRACTICE MANAGER
Medicine - General

Occupational Summary

The Department of Medicine (DOM) assistant research practice manager (ARPM) is assigned to a team consisting of a number of divisions (or affiliates) within the Department of Medicine (DoM). The DOM ARPM will work closely with the lead coordinator (RPL, divisional ARPM, Sr. CRC, etc) in each division providing upper level management across the entire study team to ensure accountability for timely project progression and metrics are met as well as regulatory compliance. The overarching responsibility of the ARPM is oversight of human subjects research and the staff within the assigned divisions and to ensure that all state, federal, sponsor and institutional regulations and policies are followed. This oversight includes, but is not limited to: implementing strategies to support the proposed studies, monitoring regulatory documentation and practices, development of SOPs to standardize research support and training, orientation and ongoing training of clinical research staff, communication with PIs as well as sponsors or other sites, human resource management of clinical research staff, financial oversite of clinical research studies, quality assurance reviews of study documentation and management, and overall problem solving and management of any issue that arises in the conduct and management of the research.

Work Performed:
  1. Human Resource Management
Provides guidance for divisions in coordinating staffing assignments and needs based on current and future workload requirements. Guidance of effort reporting and management along with divisional research leadership.

Assist divisions with determining staffing needs and coordinate posting positions with HR. May screen, interview and hire study coordinators and other research staff in conjunction with faculty and divisional research staff input.

Supervise and collaborate with divisional research leadership (lead coordinator, RPL, divisional ARPM) to perform various personnel actions including, but not limited to, hiring, performance planning and evaluation, scheduling and work assignments, disciplinary action, promotions and transfers.

Standardize and coordinate the orientation and ongoing training for study coordinators and other research staff. Ensure that current training records and required certifications are maintained.
  1. Communication
Serve as the direct point of escalation to CRU for divisional faculty and staff within the assigned team.
Serve as a communication bridge between faculty/staff and DoM-RA, providing regular, frequent updates on the status of projects in the pre-award stage while monitoring timeline metrics for each phase of the pre-award process.

Conduct regular meetings with study coordinators and other research staff in assigned team. Ensure that staff are kept abreast of CRU, departmental and institutional activities, goals, and policies and procedures.
  1. Clinical Research Operations
Provide input regarding study selection by evaluating the feasibility of new studies; including staffing and budgetary requirements, clinical and logistical considerations, and current competing studies.
After study selection, assist divisions with appropriate planning and coordination of new protocols including personnel and equipment considerations as well as institutional and federal policies that must be followed.

Monitor the status of start-up timelines for new studies including budget negotiation, IRB approval and contract execution. Maintain regular follow-up with the responsible party on items that are at risk of not meeting timeline metrics to ensure timely study start-up.

Serve as a clinical resource for budget development and justification to assist the grants and contracts administrators working on projects in the assigned team and assist with process improvements.

Monitor the progress of ongoing studies including enrollment, data collection, and close-out. Assist PIs, study coordinators and research staff in the continuous development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

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.

Serve as a mentor and direct point of escalation for CRC and other operational staff.
  1. Quality Assurance
Serve as a resource for divisions during audits conducted by the Duke Office of Audit, Risk and Compliance (OARC) HSRC section, sponsors, and regulatory authorities. Be available to assist in the review of and response to audit reports. Develop and implement corrective action plans in a timely manner when problems in research practice are identified.

Be an integral part of the Department QA Committee and conduct CRU QA audits. Assist in the development of the department QA policies and SOPs.

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.

Monitor clinical research billing reviews and assist with getting charges cleared by team in an appropriate amount of time.

REPORTING RELATIONSHIP: The ARPM will report to the Research Practice Manager.


Requisition Number
401280681

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.

Preferences:

Previous Management experience is essential.


Auto req ID

91119BR

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.

PI98212272