RESEARCH PROGRAM LEADER

Location
Durham, NC
Posted
Jan 11, 2018
Institution Type
Four-Year Institution

diversity employer



RESEARCH PROGRAM LEADER
CFM - Research and Education

Occupational Summary
Work closely with the Vice Chair of Research in the Department of Community and Family Medicine to manage the activities of research programs conducted by faculty. Under the direction of the Vice Chair, develop, manage and support a wide variety of clinical/epidemiological and population health research projects. Assist in the support and mentorship of clinical and junior research faculty, as well as trainees at different levels, including: 3rd year medical students, graduate students and post-doctoral fellows. Oversee and supervise research staff and learners. Perform and/or oversee a variety of complex duties involved in the collection, compilation, documentation and analysis of research program or portfolio data; assist with content and direction of research program or portfolio; assist with efforts to obtain and manage study or program funding. Frequently interact with other research groups or programs, serving as primary liaison and public relations lead to research program. Coordinate wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.

Description of Portfolio and Clinical Responsibilities:
Operations:
Provide oversight and training to entire unit or department with regards to subject screening. Set up unit-wide systems, policies related to subject screening. Provide oversight and training to entire unit or department with regards to maintaining subject level documentation. Set up unit-wide systems, policies related to subject level documentation. May conduct study visits independently. Serve as a unit/departmental resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc. Oversee maintenance of subject level documentation. Participate in or lead development of policies and guidances related to subject recruitment. Serve as an expert resource across unit or department. Provide oversight to study team members who conduct and document consent for participants in a variety of studies. Serve as an expert resource with regard to conduct and documentation of consent. Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings. Oversee the collection of adverse event information for an entire unit or department Provide input for AE reports. Serve as a resource to junior staff as well as the unit, department, or division staff with regard to institution and sponsor-specific prompt reporting requirements (timelines and forms). Liaise with contact for final determination of safety event outcome. Serve as a unit, department, or division resource for development of IRB documents and for guidance on IRB communications

Ethics:
Serve as a resource to unit or department to help staff and patients recognize the difference between clinical care and clinical management of research participants Provide unit, division or department-wide training in ethical conduct of research. Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Serve as a resource for development and implementation of RDSPs and DSMPs and COIs across multiple studies or study teams. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.

Data:
Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies. Serve as unit/departmental/institutional resource on ECRFs, EDCSs, technologies, and software to ensure highest quality data collection and capture Recommend and lead implementation of processes, policies, and systems to ensure data security and data provenance. Develop system/framework for QA processes for multiple studies or for entire unit. Develop unit/department - wide quality assurance systems for research data; oversee implementation. Oversee implementation of contracts and agreements within unit or department

Science:
Conduct and synthesize literature reviews independently Collaborate with various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of study aims Develop research proposals or protocols with little assistance; Identify operational shortcomings of proposals and protocols. Summarize and interpret study results, and determine application to future study procedures.

Leadership:
Lead a committee, task force, or ad hoc group. Lead scientific or programmatic presentations and publications. Serve as expert mentor to junior staff. Establish and assign the activities of multiple teams to accomplish study goals. Serve as a unit-wide expert resource for issues related to professional guidelines and code of ethics. Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.

Study and Site Management:
Determine and implement alternative solutions to accomplishing recruitment and retention milestones. Provide expert guidance to study team members to ensure participant care expenses have been set up correctly and that financial charges/expenses route in a timely manner; troubleshoot, escalate, and resolve issues. Collaborate with the financial analyst to establish financial monitoring systems. Determine when financial reports are not working as planned and collaborate with sponsor and financial managers to troubleshoot. Develop study budgets. Use system reports to ensure unit, division, or department compliance with institutional requirement/policies; assist team members with understanding these requirements and policies. Oversee study teams' maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Lead site initiation activities Develop systems and documents including process flows, training manuals, and standard operating procedures to be used unit, department, or division-wide. Develop and implement closeout procedures for multiple studies, unit, department, or division.

Communication:
Take action when communication has stalled with sites, CROs, sponsors. Responsible for items listed above, and in addition, recognize when team member communication is not going well and troubleshoot the issue.


Requisition Number
401369681

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1280 RESEARCH PROGRAM LEADER

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, 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.

Education

1.Completion of a bachelor's degree plus a minimum of four years of research experience 2.Completion of a master's degree plus a minimum of two years of research experience

Experience
Skills
Knowledge and skills relating population health and community engaged research. Experience with data management and statistical analysis software. Excellent writing skills/ manuscript and grant writing/ literature review experience

Auto req ID

96599BR

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.

PI100816685

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