Clinical Research Manager

1 day ago


Pittsburgh, PA, United States UPMC Senior Communities Full time
Purpose:
UPMC Hillman Cancer Center is internationally recognized for its leadership in the prevention, detection, diagnosis, and treatment of cancer and is the region's only comprehensive cancer center designated by the National Cancer Institute. As the preeminent institution in western Pennsylvania for the delivery of cancer care, the performance of basic, translational, and clinical research, and the education of the next generation of cancer researchers and physicians, UPMC Hillman Cancer Center is exceptionally well-positioned to contribute to the global effort to reduce the burden of cancer.

UPMC Hillman Cancer Center is currently hiring a regular full-time Clinical Research Manager to help support the Women's Oncology Clinical Research Services (CRS) team at Magee Women's Hospital in Pittsburgh, PA. This position will have a focus on leading the Women's Oncology program (Breast and Gyne Oncology) and will work a Monday through Friday daylight schedule.

The Clinical Research Manager is responsible for direct oversight of all research activities within the disease center program including but not limited to the supervision of Clinical Research Coordinators, Research Associates, and Research Data Coordinators.

The Clinical Research Services (CRS) team is made up of nearly 200 staff members who facilitate the development, implementation, coordination, internal data monitoring, and completion of oncology-focused trials at Hillman. These trials include institutional (investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials. Using a disease-specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study-specific training, data collection, and specimen collection and processing.

Responsibilities:
  • Creates a caring and compassionate patient focused experience by building healing relationships with patients, families and colleagues.
  • Responsible for day to day operations of a complex disease center, including staff oversight, conducts recruitment and evaluation, work assignment, mentor?s professional development of staff, responsible for timely activation and execution of all studies in the disease center, provides managerial oversight of smaller disease centers.
  • Oversees the day-to-day activities of the clinical research program and provides direct supervision to the clinical research staff.
  • Hires clinical research staff and has responsibility for delegating tasks, monitoring workloads, and evaluating job performance.
  • Serves as liaison between study sponsors and PIs; serving as the key coordinator for multi-center trials involving subject enrollment.
  • Demonstrates the ability to create a shared vision applies critical thinking skills and utilizes financial and quality data and conceptual knowledge in the development of the department vision and operational plan.
  • Demonstrates a passion for developing others, enthusiastically and expertly precepts new hires during the orientation process and serves continuously as a mentor.
  • Orchestrates complex change and acknowledges the psychological transition on self and others.
  • Takes responsibility for identifying his or her ongoing professional development needs and independently seeks resources and opportunities to meet those needs, such as through membership in nursing, oncology, or research organizations.
  • Develops strategies to maximize timely completion of disease center specific CRFs and data collection forms within standard of practice guidelines.
  • Involves stakeholders and experts in planning, designing, and redesigning change.
  • Disseminates new knowledge and innovations through presentations, posters, and publications.
  • Develops strategies to ensure protocol compliance and patient safety.
  • Applies critical thinking skills and utilizes quality data and conceptual knowledge in the development of the department vision and operational plan.
  • Creates developmental paths to increase the expertise of staff. Initiates innovation in staff development, clinical orientation, continuing education, and supports specialty certification.
  • Assists in institutional review board (IRB) document preparation and submission.
  • Monitors and facilitates completion of all protocol required data elements within CTMA and ensure all electronic data capture is complete and accurate
  • Supports and assist in research coordination for high profile/high risk clinical trials.
  • Accountable for the recruiting, retaining, and developing of clinical research staff.
Qualifications:
  • Bachelor's degree in nursing (BSN), Biomedical, or Business required.
  • Certification in research or clinical specialty is required.
  • BSN or Master's preferred.
  • 7 years of professional experience required.
  • Prior supervisory/management experience is required.
  • 5 years of clinical research experience with a preferred degree.
  • Must be able to demonstrate the knowledge and skills necessary to provide care and/or interact appropriately to the ages of the patients served by the department
  • Must have excellent organizational skills, meet requests from multiple individuals, and respond appropriately to sudden workload changes.
  • Must possess excellent presentation skills and written and verbal communication skills.
  • Leadership abilities
  • Excellent role model
  • Knowledge of the adult learning principles Solid/strong/good or higher on most recent performance evaluation and maintained in current practice

    Licensure, Certifications, and Clearances:
  • Act 34

    UPMC is an Equal Opportunity Employer/Disability/Veteran


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