CLINICAL RESEARCH COORDINATOR, SR
CLINICAL RESEARCH COORDINATOR, SR
Heart Center SBR
- 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.
- Design best methods for management of IP.
- Oversee implementation of and compliance with the required system for handling, dispensing and documentation of IP for sponsored protocols.
- Serve as an expert resource for study teams, DUHS procurement, billing and compliance for the proper handling of Investigational Product (IP).
- Participate in or lead development of policies and guidance's related to study level documentation.
- Participate in or lead development of policies and guidance's 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.
- Participate in or lead development of policies and guidance's related to monitoring and audits.
- Serve as an expert resource when addressing and correcting 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.
- Have familiarity with intellectual property rights, inventions patents, and technologies.
- As appropriate, understand regulations related to investigational products with sponsors.
- Coordinate with Duke core services such as Investigational Drug Service (IDS), Bio bank, etc.
- Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
- Serve as a unit, department, or division resource for development of IRB documents and for guidance on IRB communications
- 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
- Train junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety.
- Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).
- Assist with the coordination of efforts of external monitoring boards.
- Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
- Map protocol data flow and predict areas of vulnerability.
- Determine solutions for vulnerabilities for data flow plans for multiple studies.
- Use EDC systems and enter data accurately and train others in these tasks.
- Detect issues related to data capture, collection or management and suggest solutions.
- Use required processes, policies, and systems to ensure data security and provenance.
- Recognize and report vulnerabilities related to security of physical and electronic data.
- Independently investigate issues related to accuracy and completeness of data.
- Develop and run queries and reports. Recognize trends related to data quality and escalate as appropriate.
- Develop and follow SOPs for data QA. Monitor QA of study data.
- Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)
- Actively network and encourage leadership for staff within a small work group.
- Take part in a committee, task force, or ad hoc group.
- Encourage career development by actively seeking out continuing education opportunities for self and study team members.
- Participate in scientific presentations and publications.
- Serve as leader to entire unit/department.
- Define vision and direction.
- 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:
- Develop and oversee unit/department level processes to determine sponsorship, supervision or participation in trials
- Oversee unit/department level processes related to research resources and finances.
- Provide leadership/training to entire unit/department with regard to compliance with institutional requirements and other policies
- 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.
- Create unit-wide (and collaborate to create institution-wide) policies and guidance's regarding study closeout and document storage.
- Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors.
- Prepare for and lead unit, departmental, or division-wide meetings.
- Mentor junior staff to improve ability to participate in team efforts.
1202 CLINICAL RESEARCH COORDINATOR, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
Work requires one of the following: 1.Completion of a Bachelor's degree and a minimum of four years of research experience 2.Completion of an Associates degree plus a minimum of six years of research experience 3.Completion of a Master's degree and a minimum of 2 years of of research experience
Auto req ID
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.