CLINICAL TRIALS PROJECT LEADER I - CTSI
CLINICAL TRIALS PROJECT LEADER I - CTSI
Duke Translational Medicine Institute
The position will provide project management and operational leadership essential to the successful management of research projects associated with the Duke Clinical and Translational Science Institute (CTSI) Project Office. The Project Leader will utilize best project management practices and knowledge of the scientific, technical, and clinical requirements for successful early development projects to achieve project goals.
Translational Research Projects: Utilize knowledge of the drug discovery and early development processes to create and execute project work plans and revise as appropriate to meet changing needs and requirements. This will include the following general project management responsibilities:
• Ensure projects are conducted in compliance with applicable regulatory requirements and institutional standards.
• Conduct regular meetings with project team, facilitate team meetings, effectively communicate relevant project information to CTSI leadership, and communicate difficult/sensitive information tactfully. • Identify operational problems, issues, obstacles, barriers, and lessons learned across the assigned projects and make recommendations to CTSI leadership regarding solutions and process/system improvements.
• Provide oversight for delivery of project objectives. Serve as a resource to faculty and laboratory staff in identifying and accessing the appropriate complement of resources and support needed to achieve their goals, identify potentialobstacles, and collaboratively solve emerging problems. Ensure project documents are complete, current, and stored appropriately.
• Prepare status reports and track desired metrics for inclusion in periodic progress reports.
• Ensure appropriate legal and procurement documents are in effect.
• Work closely with CTSI Finance to monitor and forecast expenditures, ensure timely and accurate invoicing, and monitor receivables for projects.
• Work closely with the CTSI Grants Manager to ensure compliance with institutional, state, and federal policies. Develop and Coordinate Pilot Funding Programs: Develop and coordinate assigned pilot funding programs. This includes developing the application solicitation and submission process, coordinating the review process, ensuring all subcontracts and regulatory approvals arein place, monitoring progress, and reporting outcomes to the PI, funding agencies, and/or other key stakeholders. Contribute to improvements of systems, tools, and processes used in project management practices (timeline, financial, reporting, project communication, and review standards) for translational initiatives across the CTSI.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification.
• Strongly prefer candidates with experience in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) • Strongly prefer candidates with grant writing experience • Strong analytical and writing skills • Strong interpersonal, communication, and presentation skills • Ability to manage competing and changing priorities and multiple tasks under inflexible timelines • An individual who will be successful in this position should bring refined hands-on laboratory experience, direct experience developing in vitro and in vivo models for drug development, and direct experience in and a good working knowledge of early translation into the clinical setting.
1635 CLINICAL TRIALS PROJECT LEADER I
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 graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents: 1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2. Completion of a master's degree in Public Health, Health Administration or a related area with one year directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a minimum of three years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of four years closely related research experience. **State of North Carolina license may be required.**
None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR 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.