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Posted Job Title

Clinical Research Coordinator B/C (Abramson Cancer Center)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research 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 GU 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 GU Program Manager 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 GU 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.

Job Description

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 GU 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 GU 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 subjects 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 subjects 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.

Qualifications:

• 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:

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 GU 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 GU 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.

  QUALIFICATIONS:

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 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.

Position is contingent upon continued funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$43,919.00 - $67,046.00 Annual Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

• Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.

• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.

• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.

• Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.

• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.

• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.

• Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.

• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.

• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

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  To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

  The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.