Clinical Research Coordinator A

Clinical Research Coordinator A

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title
Clinical Research Coordinator A

Job Profile Title
Clinical Research Coordinator A

Job Description Summary
The Clinical Studies Unit within the Department of Dermatology at the University of Pennsylvania is actively seeking a dedicated, full-time Clinical Research Coordinator to assist in the organization, coordination and implementation of complex cancer studies involving a wide variety of investigational products and various sponsors. The position will report directly to the Director of Clinical Research Operations and collaborate with Physician Investigators on research protocols This individual will be responsible for supporting the following aspects of clinical trial coordination in medical dermatology including subject recruitment, detailed data collection and 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 Clinical Studies Unit Research Team. We are looking for an enthusiastic, professional and committed team member to work closely with our clinical research investigators, Research Team Leaders, and regulatory coordinator. The Department of Dermatology at the University of Pennsylvania makes fundamental discoveries in clinical and basic science research on skin biology. We regularly rank among the top three dermatology departments in National Institutes of Health (NIH) funding, and we are one of the 6 centers in US designated as a Skin Biology Disease Research Center by the NIH.
We are looking for a professional who thrives in a collaborative, fast-paced environment and is passionate about advancing dermatological research. This role offers an exciting opportunity for career growth, with comprehensive training and development provided to support the CRC in their professional journey from initial onboarding to ongoing career advancement within clinical research.

Job Description

This individual will work under general supervision

The CRC will assist in the coordination of complex medical dermatology 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. Additional details of these responsibilities are provided below:

• Coordinate the conduct investigational drug, biospecimen, observational industry and investigator initiated clinical trials and registries within CSU.
• 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,
• Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with Sponsors and cooperative groups as directed by CSU Director and Research Manager.
• Assist in planning and implementation of patient recruitment into studies (involves reviewing medical records of upcoming new and return patient clinic visits and discussing with members of the research team and investigators, reaching out to potential referring physicians, approaching potential subjects in the clinic or speaking to them by phone, asking pre-screening eligibility questions, etc.). May assist in the clinic to explain a trial and conduct informed consent with the patient and family.
• Assist in the scheduling and coordination of 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).
• Review subjects' source from visits per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality.
• Assist in the development/maintenance of electronic study specific case report forms (i.e. REDCap, 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.
• 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.

Job Responsibilities

• 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 biospecimen and data collection research within the CSU. 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.
• Assist in planning and implementation of patient recruitment into studies (involves reviewing medical records of upcoming new and return patient clinic visits and discussing
  
  with members of the research team and 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 assist in the clinic to explain a trial and conduct informed consent with the patient and family.
• Assist in the scheduling and coordination of 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). May assist in the coordination of adequate investigational agent supply with sponsor and IDS as needed and may assist with drug accountability and appropriate investigational agent diary completion.
• Participate in the development/maintenance of study specific case report forms (i.e. REDCap,) 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. Responsible for IND reporting and/or assisting Sponsor with annual IND reporting.
• Coordinate and participate in study team 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 be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues.
• Other duties and responsibilities as assigned

Qualifications

Bachelor's degree and 1-2 years of clinical trial/clinical research experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1)

Effective problem-solving skills; (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) ability to work flexible hours; (6) knowledge of IRB and Human Research Protection Regulations; (7) Experienced in Microsoft word and excel

This position is contingent upon funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$43,888.00 - $49,554.00 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


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