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RESEARCH PROGRAM LEADER

Job description


diversity employer



RESEARCH PROGRAM LEADER
Population Health Sciences

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. May maintain subject level documentation for all studies independently.

Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. Participate in or lead development of policies and guidance related to study level documentation.

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.

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.

Possess thorough understanding of intellectual property rights, inventions, patents, and technologies. Coordinate with Duke core services such as Investigational Drug Service, Biobank, etc.

Coordinate necessary agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.

Ethics: 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 conductand protect vulnerable populations.

Serve as a resource for development and implementation of RDSPs and DSMPs and COIs across multiple studies or study teams.

Data: Predict areas of vulnerability for data flow for multiple studies or across a unit, department or division.

Design data flow plans that include elements related to data capture, storage, management, quality, and preparation for analysis; implement across multiple studies or at unit, department or division level. Independently design ECRFs and EDCs to collect data according to protocol.

Select methods of data capture and discuss advantages and disadvantages of each. Implement at the unit, division, or departmental level.

Develop system/framework for QA processes for multiple studies or for entire unit.

Make determinations regarding complex data contracts/agreements.

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 proposals or protocols independently.

Assess and determine solutions for 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. May serve as mentor to other staff.

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 unit, department, division's 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.

Work with sponsors and study teams to arrange required sponsor training.

Provide feedback to the study team members; and serve as an institutional resource to the study visitors Create unit-wide (and collaborate to create institution-wide) policies and guidance regarding operational planning Develop and implement closeout procedures for multiple studies, unit, department, or division.

Communication: Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. Prepare for and lead team meetings.

Recognize when others need to be brought into the conversation and escalate appropriately.

Expand on the ideas of peers or team members.

Take an active role in including others in decision-making.

Description of Portfolio and Clinical Responsibilities: Manage the program, portfolio, or shared resource by employing strategies to reach established short- and long-term goals.

Monitor the program or portfolio success using relevant reports. Investigate trends and implement modifications to improve the research program or shared resource effectiveness.

Manage research program/portfolio and/or shared resource operations; monitor and adhere to established budget; manage and train staff.

Ensure that institutional communications are shared with the staff within the research program.

Establish and maintain internal Duke and external communications to accomplish program objectives and ensure successful research partnerships.

Represent the research program and research areas at the institutional level and with collaborators external to Duke.

Portfolio Management: Responsible for overseeing research studies and department initiatives in the data core.

Multiple studies (6-8) related to secondary data analysis using administrative claims data and clinical data sources such as electronic health records.

Studies are made up of 5-7 faculty and research staff. Budgets range up to $700,000 in direct costs.

Clinical responsibilities:
• Other: Type of Research The data core in the Department of Population Health Sciences conducts secondary data research. Key departmental data resources include administrative healthcare claims data, electronic health records data, and clinical registries.

These data sets are used to answer research questions in: health services research and policy, health disparities research, and health outcomes research. In addition to department faculty, study teams typically involve clinicians, biostatisticians, programmers, research fellows, and graduate students.

Special Skills:Detail-oriented, excellent written and verbal communication skills, time management to prioritize competing priorities.

Enjoy working on highly collaborative project teams.

Requisition Number
401344401

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.

Preferences:
Financial management skills

Auto req ID

94719BR

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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Job No:
Posted: 5/12/2018
Application Due: 7/11/2018
Work Type:
Salary: