Clinical Research Coordinator B/C

Clinical Research Coordinator B/C

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific medical oncology cancer programs within the ACC.

The ACC CRU Myeloma Research Team seeks a full-time Clinical Research Coordinator to organize, coordinate and implement complex cancer studies involving a wide variety of investigational products and various sponsors. This position will report directly to the Lead Clinical Research Nurse and work directly with Physician Investigators ("PI") on clinical research performed. He/she will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards.

The Clinical Research Coordinator (CRC) is an integral and essential member of the ACC CRU Research Team. We are looking for an enthusiastic, professional, and committed team member to work closely with our clinical research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an exceptional rating from the National Cancer Institute (NCI) and is considered one of the top 10 cancer centers in the country. We are looking for a CRC that will help accelerate this momentum through the conduct of cutting-edge clinical trials. Career Development Opportunities: The ACC is focused on career development of CRCs and offers an advanced infrastructure of leadership and training to guide and support new CRCs from initial training, to continued professional growth.

Clinical Research Coordinator B Responsibilities

This individual will work under general supervision

The CRC will be responsible for the coordination of complex oncology clinical research protocols, including 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 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. Additional details of these responsibilities are provided below:

• Coordinate the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the ACC CRU Research Team.
• Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. Coordinate completion and appropriate documentation of new study staff training during any staffing transitions or for coverage purposes.
• Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by the ACC CRU Research Team Program Manager.
• Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential participants in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.). May participate in the clinic to explain a trial and conduct informed consent with the patient and family.
• Develop, schedule and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP) (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).
• Monitor participants per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality.
• Communicate clinical trial patient activity to the investigational drug pharmacy (IDS) to ensure adequate drug supply. Coordinate investigational agent supply ordering with sponsor and IDS as needed. Ensure drug accountability and appropriate investigational agent diary completion.
• Participate in the development/maintenance of electronic study specific case report forms (i.e., REDCap, CTMS etc.) and source document tools. Organize and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report forms, and research charts.
• Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. Maintain clinical trial databases by completing case report forms typically within 5 business days of subject visits and resolving data queries within 10 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission. Responsible for IND reporting and/or assisting Sponsor with annual IND reporting.
• On behalf of the site, participate in weekly or bi-weekly Sponsor teleconferences to review the status of ongoing patients and slot assignments/allocations for next dose levels; share study-wide updates/issues with the Research Team's Program Manager and study team members who were not able to participate. Coordinate and participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Provide regular study and enrollment updates to the research team. Work as a part of the research team to maximize the efficiency and quality of research performed, including developing work instructions.
• May act as a mentor to coordinators who have joined the unit with less research experience.

Clinical Research Coordinator C:

The Clinical Trials Coordinator C will have the same duties as B but will include the following:

• This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to the supervisor.
• Work directly with physicians to assist with design, set-up and execute studies. Be responsible for writing investigator-initiated IND/IDE clinical trials in collaboration with faculty supervisor. Speak at investigator meetings or site initiation visits for IITs where collaborating physician is the Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; contribute to the preparation of study abstracts, posters, manuscripts, and grant applications.
• May participate in and support budget preparation for trials as needed. May support a clinical trial budget through each phase of development, resolving issues and queries with input from the Research Team's PM/PI as required.
• Independently coordinate complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) clinical trials and registries within the ACC CRU Research Team. May schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice, detailed documentation of study activities.
• Act in lead capacity in coordination of ACC CRU Research Team projects and assist Research Team Managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support (e.g., regulatory submissions and data entry).
• May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues.

Position involves potential cross coverage and/or re-assignment amongst ACC CRU Research Teams depending on business needs. Position is contingent on continued funding.

Qualifications

• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
• Clinical Research Coordinator B: Bachelor's degree and 2-3 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple research projects; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) knowledge or experience in cancer 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.
• Clinical Research Coordinator C: Bachelor's degree and 4-5 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple therapeutic research protocols; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) knowledge or experience in cancer preferred