Clinical Research Coordinator B or C

Employer
University of Pennsylvania
Location
Philadelphia
Closing date
Jul 15, 2033

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Administrative Jobs
Academic Affairs, Research Staff & Technicians

Job Details



Clinical Research Coordinator B or C

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.

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 B or C

Job Profile Title
Clinical Research Coordinator B

Job Description Summary
The Clinical Research Unit Airways Research Team at the Abramson Cancer Center of the University of Pennsylvania seeks a full-time Clinical Research Coordinator to organize, coordinate and implement studies involving a wide variety of investigational products and various sponsors. 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

THIS POSITION IS CONTINGENT UPON FUNDING

Job Description

Clinical Research Coordinator B:

This individual will work under general supervision.

Assist unit managers with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. 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 supervisor.

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 Clinical Research Program. Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. Maintain Delegation of Authority Logs. Coordinate completion and appropriate documentation of study staff training.

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.).

Participate in clinic to explain the trial and provide informed consent to the patient and family. Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (“GCP”) (e.g. scheduling subject 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). Ensure drug accountability and appropriate diary completion. Ensure adequate drug supply and assist Pharmacist with ordering if needed. Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Participate in the development/maintenance of study specific case report forms and source document tools. May include the development and management of REDCAP web sites for internet data capture. 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 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 unit managers 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. Prepare agendas and record minutes for circulation. Provide regular updates to the research team and unit managers. Assist unit managers in meeting project timelines. Participate in working groups within the Airways Clinical Research Program that will maximize the efficiency and quality of research performed, including developing SOP's. May act as a mentor to coordinators who have joined the unit with less research experience

Clinical Research Coordinator B: Bachelor's degree and 2-4 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 solid cancers 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 Research 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 supervisor.
  • Work directly with physicians to design, set-up and execute studies. Be responsible for writing investigator initiated / clinical trials in collaboration with faculty supervisor. Speak at investigator meetings or site initiation visits for IITs where physician is the national Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; assist with literature reviews; contribute to the preparation of study abstracts, posters, manuscripts and grant applications.
  • Work in conjunction with unit managers
  • Participate in budget preparation for trials as needed. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required
  • Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I - IV clinical trials and registries within the Airways Clinical Research Program. This includes managing various aspects of multi-center trials such as working with partnering institutions on budgets and IRB documentation, and monitoring external research sites.
  • Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (“GCP”) (e.g. scheduling subject 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, coordinating treatment administration and/or procedures with physician or NP, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).
  • Act in lead capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinators/assistants who provide 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. Act as back-up to the unit managers when required.


Clinical Research Coordinator C: Bachelor's degree and 4-6 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 solid cancers 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.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$42,953.00 - $77,315.00

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.


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Clinical-Research-Coordinator-B-or-C_JR00029042





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Organization

Welcome to the University of Pennsylvania! Penn is the largest private employer in Philadelphia and is a world-renowned leader in education, research, and innovation.  

Across our 12 highly-regarded schools, more than 25,000 students, and more than 4,000 faculty members, we become one university: a wide-ranging, ever-changing community that draws its strength from a multitude of races, ethnicities, genders, sexual orientations, historical traditions, ages, religions, disabilities, veteran status, interests, perspectives, and socioeconomic backgrounds. 

Penn carries on the principles and spirit of its founder, Benjamin Franklin: entrepreneurship, innovation, invention, outreach, and a pragmatic love of knowledge. Franklin's practical outlook has remained a driving force in the university's development. To learn more, visit About Penn

Vision

 

As engines of knowledge and new ideas, universities have the unique potential to define the future rather than be defined by it; to pioneer change rather than merely manage it. To do so requires a plan both visionary and pragmatic. The Penn Compact 2022 motivates community members to innovate, be radically inclusive, and positively impact their local, national, and global communities. 

 

Penn’s fundamental priorities — increasing access, integrating knowledge and engaging locally, nationally and globally — are supported by the three core values that make us uniquely Penn: inclusion, innovation, and impact. 

 

Learn about the signature initiatives of the Penn Compact 2022:  

 

Diversity 

 

Understanding and appreciating diversity is one of Penn's most important priorities and is fundamental to success in today's world. 

 

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. 

 

To learn more about Diversity and Inclusion at Penn visit: 

 

Benefits 

 

Penn offers a wide range of benefits and perks - from Penn's retirement Matching Plan to bike repair stations to access to the full LinkedIn Learning library to adoption assistance to workshops at the letterpress and book arts studio and much more! 

 

Campus and Beyond

 

We invite you to explore our campus and its stately buildings and state-of-the-art facilities. 

 

Try our self-guided tour! Come and visit

 

Learn about sustainability at Penn

 

News 

 

Stay up-to-date with Penn's response to COVID-19: Coronavirus Information & Resources

 

Penn supports news publications that tell the ongoing story of the University community, communications services for external media, telephone and video services, and other media resources: Campus Media 

 

Connect with us!  

 

Instagram: @uofpenn 

Twitter: @Penn 

 

 

Find Us
Telephone
(215) 898-7372
Location
3451 Walnut Street
Philadelphia
PA
19104
United States

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