University of Kansas Medical Center

SOM KC Internal Medicine - Pulmonary, Critical Care, and Sleep Medicine. The Division of Pulmonary, Critical Care, and Sleep Medicine is seeking a highly self-motivated, hardworking, and talented Clinical Trials Research Project Manager to support and lead defined operational goals for the growing and dynamic portfolio that includes industry sponsored and federally funded clinical and translational trials.. This role will work collaboratively with the Pulmonary Research Project Director, Division Director, divisional PIs, Internal Medicine Research Office, and divisional staff to support the day-to-day operations at a divisional level.. Certified as a Clinical Research Coordinator (CCRP/CCRC). Experience as a Senior Clinical Research Coordinator, Clinical Research Supervisor, or Clinical Trials Manager.

research project manager

Department SOM KC Internal Medicine - Pulmonary, Critical Care, and Sleep Medicine Pulmonary and Critical Care Medicine Position Title Research Project Manager - Internal Medicine (Pulmonary) Job Family Group Professional Staff Job Description Summary The Division of Pulmonary, Critical Care, and Sleep Medicine is seeking a highly self-motivated, hardworking, and talented Clinical Trials Research Project Manager to support and lead defined operational goals for the growing and dynamic portfolio that includes industry sponsored and federally funded clinical and translational trials. This role will be responsible for the management of the Pulmonary Administrative Support Team and oversee system integration, onboarding, and offboarding for appropriate clinical trial staff. This role will work collaboratively with the Pulmonary Research Project Director, Division Director, divisional PIs, Internal Medicine Research Office, and divisional staff to support the day-to-day operations at a divisional level. Job Description Required Qualifications Education/Certification <ul><li>Bachelor’s degree or an equivalent combination of post-secondary education and work experience that equals 4 years.</li><li>Certified as a Clinical Research Coordinator (CCRP/CCRC) </li></ul>Work Experience <ul><li>Five years direct experience in research related activities.</li><li>Experience as a Senior Clinical Research Coordinator, Clinical Research Supervisor, or Clinical Trials Manager.</li><li>Extensive working knowledge of FDA regulations, Good Clinical Practices (GCP) guidelines and Regulations applicable to clinical trial study implementation and data management. </li></ul>Preferred Qualifications Education: Master’s degree Skills <ul><li>Ability to organize or schedule people or tasks, to develop realistic plans while being sensitive to the needs of different constituencies, time constraints, and resource availability.</li><li>Ability to act in solving problems while exhibiting judgment and a realistic understanding of issues. </li></ul>Management Job Duties <ul><li>Supervision over multiple direct reports and coordination with Clinical Trials Project Director on performance evaluations.</li><li>Provides professional direction to study teams that encourages team building, cross-coverage, and an efficient goal-oriented team.</li><li>Creates or assists in creating divisional SOPs.</li><li>Provides oversight and direction the Pulmonary Division Administrative Support Team to ensure proper conduct in all aspects of a clinical trial being performed at each study site. </li></ul>Operational Oversight And Support Of Division Study Teams <ul><li>Supports divisional teams as needed on coordinating all aspects of clinical research trials, which include tactical management, administration, and leadership of project teams in order to ensure the project proceeds on time and within budget parameters.</li><li>Provides oversight and direction to Pulmonary Admin Support Team to ensure proper conduct in all aspects of a clinical trial being performed. Supports study teams in the planning, implementation, and coordination of clinical trials, including multi-site, sponsored by industry, government, non-profit foundations, or private organizations.</li><li>Collaborate closely with the clinical trial principal investigator and their study team, external site investigators and staff (for multi-site trials) and various administrative organization across the institution.</li><li>Assists clinical trial principal investigator with experiment design and implementation, and data collection and analysis.</li><li>Coordinates project tasks among and between large academic research institutions with minimal supervision</li><li>Assists study teams as needed to ensure the shortest possible timeframes for start-up.</li><li>Oversight of quality assurance plan and provides ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol.</li><li>Assists in budget review and development, including Coverage analysis review, Velos calendar review creation and progress.</li><li>Responsible for the management of system integration onboarding and offboarding for appropriate clinical trial staff.</li><li>Assist with onboarding, offboarding, and training for assigned clinical trial staff.</li><li>Acts as a Clinical Research Supervisor as needed:</li><ul><li>Complete study related trainings and certifications.</li><li>Administer informed consent documents to study participants.</li><li>Perform human participant assessments.</li><li>Process serum and plasma samples for storage and shipment.</li><li>Assist study teams in creating study documentation (e.g. Case Report Form(s), source documents, surveys etc.).</li><li>Assist study teams in regulatory files maintenance (paper based and/or Complion) and training.</li><li>Assist study teams on protocol deviations recognition, reporting and develops Corrective Action Plans and tracking.</li></ul><li>Other duties as assigned. </li></ul>Required Documents <ul><li>Resume/CV</li><li>Cover Letter </li></ul>Comprehensive Benefits Package Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html Employee Type Regular Time Type Full time Rate Type Salary Compensation Statement The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above. Pay Range $83,000.00 - $131,000.00 Minimum $83,000.00 Midpoint $107,000.00 Maximum $131,000.00

START NEW SEARCH