"Clinical Research Coordinator B/C - Epidemiology Division"

Job Description Summary

The Clinical Research Coordinator B/C will assist in the coordination and management of multiple clinical trials along with other research projects and responsibilities in the Infectious Diseases C-STAR Research Team and MOTION Laboratory Group.

Duties include, but not limited to, the following: screening, recruiting, consenting and enrolling eligible subjects per protocol using GCP guidelines. Scheduling clinical and research visits, interacting with clinicians and staff to schedule and oversee research testing, assist or coordinate specimen collection (including coordinating serum collections from clinical labs) and transport/shipment of specimen samples, preparing trials for audits and inspections. The CRC will participate in study team meetings and ongoing protocol training/compliance meetings and will be expected to adhere to all University of Pennsylvania, FDA, and GCP guidelines.

The CRC-B/C will be responsible for accurate data collection and overseeing the quality of the clinical trial data and records, scheduling and conducting study initiation and monitoring visits, and participating in ongoing study protocol training. The CRC B/C is also responsible for research lab specimen processing/handling. The CRC will demonstrate vigilance in patient safety, protocol compliance, and data quality, and will participate in data organization for research publications, with potential for co-authorship. Study enrollment/activities may occasionally require driving/traveling to other sites located offsite from University of Pennsylvania’s Main Campus. This position requires flexibility to work occasional nights/weekends.

Clinical Research Coordinator C (CRC-C): In addition to performing all duties above, the CRC-C is expected to run projects independently, with minimal supervision. May act in a lead capacity or as back-up to the supervisor. CRC-C is expected to draft complex documents including protocols, and Manual of Procedure (MOP).

Job Responsibilities

• Coordinate and conduct clinical trials. Promote good clinical practice in the conduct of clinical trials. Demonstrate knowledge of the federal regulations for the conduct of clinical studies and human subject protection.
• Act in lead capacity in coordination and conduct of clinical trials and other projects and assist Research Team Managers in overseeing execution of project timelines as well as completion of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance visits.
• Assure compliance with the protocol and regulatory requirements includes collecting, recording, and maintaining data and source documentations. This involves organizing, participating and assisting in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.
• Interface with regulatory authorities (OCR at Penn), Sponsors and any cooperative groups.
• Coordinate and conduct all activities around the clinical trials, including: subject recruitment, informed consent, chart maintenance and data entry; being actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and follow-up patient visits and discussing with investigators, reaching out to treating physicians, approaching potential subjects, determining if subjects meet pre-screening eligibility requirements, etc.). Explain trial and conduct informed consent with the patient and family in detail, educating patients and family members as well as monitoring subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. This includes completing relevant trainings to function in the role including but not limited to electronic databases, and processing/shipping specimens (REDCap, CRMS, PennChart, LabVantage). May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues. Coordinate completion and appropriate documentation of study staff training.
• Schedule and oversee subject visits and any necessary testing and specimen collection needed according to protocol and in accordance with Good Clinical Practice, detailed documentation of study activities (e.g. scheduling participant visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities). This involves communicating and coordinating all aspects of dealing with and handling the investigational product with the manufacturing/research lab, according to protocol. Oversee study preparation and sample processing, transport and analysis.
• Database management and analysis. This involves collection, review and reporting timely, valid, accurate study data; obtaining records required to complete case report forms; updating/maintaining study record in the Clinical Research Management System (CRMS) in real-time. This duty also includes maintaining clinical trial databases by completing case report forms in a timely manner (i.e. REDCap, CRMS etc.) and source document tools (PennChart); organizing and maintaining all documentation required: source documentation, case report forms, and research charts.
• Participate in weekly meetings to provide enrollment updates, to review the status of ongoing patients; discuss updates/issues with the Research Team’s Program Manager and prepare updates/meeting minutes. Work as a part of the research team to maximize the efficiency and quality of research performed.
• Other duties and responsibilities as assigned such as: inventorying supplies, maintaining equipment; performing study enrollment/activities that may occasionally require driving/traveling to other sites located offsite from University of Pennsylvania’s Main Campus.

*Position contingent upon continued funding*

Qualifications

The CRC-B/C ideally will have prior experience working with epidemiological studies within all aspects of infectious diseases.

Clinical Research Coordinator B: 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.

Clinical Research Coordinator C: Bachelor’s degree and 4-6 years of related experience, or equivalent combination of education and experience, are required.

Additionally, the CRC B/C will have the following: (1) practical experience coordinating the day-to-day activities of multiple research protocols (2) effective verbal and written communication skills (3) ability to learn new methods quickly and multi-task (4) demonstrate the ability to work as part of a team as well as independently (5) knowledge or experience in clinical trials preferred but not required (6) ability to work flexible hours (7) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines

This position requires flexibility to work occasional nights/weekends.