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Description

Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.

Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?

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.

+ The 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 adult subjects. 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, enrollment and subject visits, in person and telephonic as appropriate.

+ Accommodate the diverse needs of study subjects. Provide psychosocial support. 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.

+ 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 visits, referrals to IMPaCT and HUP Harvest, ensuring all data collection completed and recorded on the appropriate forms and electronic documents, collection and dissemination of subject data entry of subject data in study databases, participation in study visits and meetings, participation in the conduct of audits.

+ 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.

+ Collect, review and report timely, valid, accurate study data within the timelines specified by the 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.

+ Attends 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:

+ RN or APP License (Preferred)

Education or Equivalent Experience:

+ Bachelor of Arts or Science (Required)

+ Education Specialization:Public Health, Healthcare Administration, NursingEquivalent Experience:•And 1+ years 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.

+ Computer literacy required and proficient in Excel preferred.

+ Excellent written and verbal skills required along with problem resolution skills and attention to details.

We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.

Live Your Life's Work

We are an Equal Opportunity employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.

REQNUMBER: 298232