Research Coordinator- Hospital of the University of Pennsylvania

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The Magnet Division of the Hospital of the University of Pennsylvania is seeking a Part-Time Research Coordinator to join their team:

Summary:

The HUP Community Engagement team's Clinical Research Coordinator is responsible for managing a multilayered health equity study focused on improving maternal health outcomes for prenatal high risk population with food insecurity. The CRC involves a variety of collaborators and participants. The CRC serves as day-to-day operations contact while ensuring subject safety and well-being. They are charged with protocol execution, preparation and oversight of regulatory documentation of study protocols, consent forms, adverse event, and other essential communications and submission to the IRB (local, CIRB). Participates in the development/management of study budgets. Manages and maintains study and data integrity (pre-initiation, active study, follow up, and study closure. Interface with the regulatory authorities, sponsors and cooperative groups. Th Community Engagement CRC is responsible in ensuring all Helen O. Dickens Center for Women's Health patients are screened for eligibility for opened clinical studies. They are responsible for detailed data entry, training of students, collaboration with Community Health Worker program and report to Co-Investigator of the study. They report relevant findings at the meeting. They participate alongside physicians, nurses, dietitians and other clinical staff members to explain the trial schedule of events and assist with coordination of assessments and procedures. They work closely with IMPaCT Community Health Worker program, HUP Harvest food pantry program, and Helen O. Dickens Center team members. Must be able to work independently with minimal supervision. Function as a positive role model, promote multidisciplinary collaboration and identifies and implements research studies. The successful candidate will comply with all policies relating to UPHS, JCAHO, Good Clinical Practice (GCP) and other regulatory standards.

Responsibilities:

• Care for subjects in all age groups. Implements care delivery model in collaboration with the Principal Investigator (PI) and study team and in accordance with research guidelines and GCP. Coordinate activities of community engagement team in caring for subjects. Implements or provide oversight of screening, referral, and scheduling subjects for appointments, in person and telephonic as appropriate.
• Accommodate the diverse needs of study subjects and their families. Provide psychosocial support and make suggestions or referrals to other professional staff (i.e. social worker, chaplain) as needed. Ensure subjects are educated regarding protocol specifics. Intercept and respond to subject's phone calls and emails. Anticipates subject's concerns and provide appropriate reassurances. Handle any questions subjects may have regarding protocol specifics, investigational products, lab results, effects of therapies, medications, and symptom management within clinical scope and level of expertise and referring other questions to the PI or medical team in order to obtain guidance.
• Demonstrates expertise in subject assessment related to social determinants of health and impact on disease. Obtains information and interprets it in terms of each subject's needs. Must be able to prioritize urgent and routine problems including changes in subject's condition or lab values which require immediate intervention by the PI or medical team. This involves a thorough understanding of disease processes, treatments, side effects, short and long-term complications.
• Independently manage all aspects of complex clinical trials which may include, but is not limited to: creating workflow and oversight on; screening and confirming eligibility; obtaining informed consent; enrollment and registration of study participants; scheduling study-related office visits, referrals to IMPaCT and HUP Harvest; ensuring all data collection completed and recording assessment findings, education, interventions and plans on the appropriate forms and electronic documents; reviewing subjects' test results for abnormalities and trends, and collaborating with MD or NP for follow-up; collection and dissemination of subject data; entry of subject data in study databases, participation in initiation, monitoring, and close-out visits with sponsors and CROs; participation in the conduct of audits by study sponsors, CROs, the FDA, Cooperative Study Groups, (NRG, ECOG-ACRIN, SWOG, etc.), the University of Pennsylvania's CTSRMC, and other groups.
• Collaborates with Principal Investigator and Co-Principal Investigator to assist in the review and selection of community engagement study.
• Provides regulatory oversight. Participate in the development/maintenance of IRB submissions and regulatory files, including submission of study documents to all applicable institutional committees (e.g., IRB, CTSRMC) for initial approval, continuing reviews and for approval of any amendments.
• Maintains record of subjects of where they are in study and compiles routine reports.
• Plans and participates in subject recruitment, enrollment, and retention activities.
• Screens and determines potential eligibility of patients and discusses study with PI and Co-PI for a collaborative approach to the patient.
• Enrolls eligible patients after obtaining informed consent and coordinates study events according to study protocol.
• Collaborates and communicates with essential members of HUP Harvest, IMPaCT, Helen O. Dickens Center, to conduct studies in a team building manner. • Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality.
• Provides close supervision of the study patient while enrolled in the study to ensure safety and follow-up appropriately.
• Monitor subject status and treatment side effects throughout the entire study period in concert with investigators. Review all clinical and laboratory data and adverse events, reporting in real-time to the PI for assessment, review and appropriate follow-up, and communicate with medical staff regarding management of any adverse events.
• Collect, review and report timely, valid, accurate study data within the timelines specified by the Clinical Trials Agreement and Study Protocol.
• Fulfills all aspects of data management responsibilities including IRB submissions, abstracting, follow-up, tracking of results, communicating with physicians and sponsors, and research participants within the required time frames.
• Fulfills all aspects of study intervention management, monitoring, and accounting with accuracy.
• Responds to sponsor queries and requests in a timely basis. Works collaboratively with site monitors and auditors.
• Attends off-site meetings, protocol reviews and training related to specific research projects as able.
• Performs responsibilities with a concentrated focus and attention to details and maintains a high level of accuracy.
• Prepares for audits collaboratively with the Community Engagement team and provides assistance to the auditors.
• Maintains required research educational requirements, (i.e. HSP, GCP).

Credentials:

Current Pennsylvania RN or APP License (Preferred)

Education or Equivalent Experience:

Bachelor's Degree (Required)
1+ years of experience (Required) providing direct care or public health program interventions to maternal health populations
Experience as a research coordinator (Preferred)
Proficient in regulatory component of clinical research (Preferred)

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