RESEARCH PROGRAM LEADER - SON

Location
Durham, NC
Posted
Jul 19, 2017
Institution Type
Four-Year Institution

diversity employer



RESEARCH PROGRAM LEADER - SON
SON-FACULTY AND STAFF

Job Description

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.
  • 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. Implement innovative solutions to maximize recruitment and retention
  • 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.
  • Participate in or lead development of policies and guidances related to monitoring and audits. Serve as an expert resource when addressing and correcting findings.
  • Oversee the collection of adverse event information
  • Direct study team's compliance with submission and completion of AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
  • Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.

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.

Data:
  • Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies.
  • 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.
  • May assist with development of, or develop, guidances and policies related to research data provenance and security.
  • Serve as unit/departmental resource to others regarding data provenance and security.
  • Oversee the creation and use of queries, summaries, and reports.
  • Recognize trends; escalate as appropriate.
  • Develop quality assurance systems for research data; ensure that QA SOPs are updated and followed by study teams.
  • Implement quality assurance systems across multiple studies, or across entire unit, department or division. reports.
  • Recognize trends; escalate as appropriate. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)

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:
  • Provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups.
  • Successfully lead a committee, task force, or ad hoc group at the division, unit, department or institution level. Lead cross-functional committees or task forces charged with improving study processes.
  • Independently lead scientific or programmatic presentations or 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 unit, department, division's compliance with training requirements. Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research.

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
  • 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:
  • Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors.
  • Responsible for items listed above, and in addition, recognize when team member communication is not going well and troubleshoot the issue.

Description of Portfolio and Clinical Responsibilities:
  • Portfolio Management (Effort 50%): Lead development, implementation, evaluation and oversight of the TEAM UP study.
  • Lead content and direction of research program, lead and report on funding efforts, lead and develop nursing staff education/training programs.
  • Lead communications with other research groups/programs and external entities, including providers, technology companies, stakeholders and policy makers.
  • Serve as primary liaison and public relations lead for research program.

Clinical responsibilities:
  • Manage a national, multi-center research program. Independently manage and coordinate research activities.
  • Lead communications with other research groups/programs and external entities, including providers, technology companies, stakeholders and policy makers.

Special Skills Doctoral degree in nursing preferred. Experience in research study and grant management.

Requisition Number
401297530

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, 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

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

Auto req ID

92004BR

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.

PI98727215