University of Pennsylvania - Philadelphia, PA

posted 7 months ago

Full-time - Entry Level
Philadelphia, PA
Educational Services

About the position

The Clinical Research Coordinator B position at the University of Pennsylvania's Department of Dermatology is primarily responsible for implementing study protocols and data collection procedures for Phase IV clinical trials and observational studies. This role requires the candidate to work closely with senior clinical research staff to ensure compliance with University of Pennsylvania, Good Clinical Practice (GCP), Informed Consent Form (ICF), and FDA guidelines. The ideal candidate will possess strong communication skills and experience in direct patient interaction within clinical settings, demonstrating the ability to manage their own workload with minimal to moderate supervision. In this role, the Clinical Research Coordinator B will be tasked with various responsibilities, including patient recruitment and enrollment, scheduling and coordinating study visits, and collecting and recording essential patient data. The coordinator will also be responsible for drafting regulatory documents, managing data entry and monitoring, and supporting the research team in various capacities. The position requires a proactive approach to ensure that recruitment and enrollment goals are met within specified timelines, and the coordinator will serve as the main point of contact for study participants throughout the research process. The work environment is dynamic and may involve responsibilities outside of the standard 8:30 am to 5:00 pm workday. The position is contingent upon funding and requires a Bachelor's Degree with 2-3 years of related experience in research and clinical study methodologies or an equivalent combination of education and experience.

Responsibilities

  • Identify and implement strategies for successful patient recruitment and enrollment goals.
  • Initiate and maintain communications with health care providers and staff for patient referrals.
  • Schedule and coordinate screening/enrollment visits and perform screening procedures per study protocol.
  • Complete informed consent procedures with patients during clinic visits and scheduled research encounters.
  • Track recruitment and enrollment progress and prepare weekly updates for the research team.
  • Coordinate training and monitoring activities for external study sites and maintain communication with research staff at those sites.
  • Schedule and coordinate all study data collection visits with various clinics/providers.
  • Collect and record patient demographics, social histories, vitals, and other relevant data.
  • Collect blood samples and coordinate visits for other sample collections.
  • Work with providers on the collection of bio-specimens and prepare samples for processing and storage.
  • Track and maintain records of bio specimens and PET/CT scans.
  • Communicate with Penn IDS to track study drug inventory and ensure proper drug storage and shipping.
  • Draft informed consent forms, data collection forms, and protocol revisions for regulatory submissions.
  • Prepare components of IRB submissions and external study site regulatory documentation.
  • Assist senior clinical research staff in communications with study sponsors and provide documentation and enrollment updates.
  • Coordinate efforts between study team and database developers, review data queries, and assist with data cleaning and analysis preparation.
  • Support and interact with PIs, co-investigators, research managers, and other CRCs and staff.
  • Maintain all relevant trainings and certifications and adhere to University, GCP, and FDA guidelines.

Requirements

  • Bachelor's Degree with 2-3 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required.

Benefits

  • Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance.
  • Tuition assistance for employees, spouses, and dependent children.
  • Generous retirement plans including Basic, Matching, and Supplemental options.
  • Substantial time away from work for personal needs.
  • Long-term care insurance for faculty and staff and eligible family members.
  • Wellness and work-life resources to support health and balance.
  • Professional and personal development resources.
  • Access to University resources and cultural activities.
  • Discounts on goods and services for faculty and staff.
  • Flexible work hours and options for non-traditional work arrangements.
  • Adoption assistance for qualified expenses related to legal adoption.
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