CTSRMC Coordinator

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CTSRMC Coordinator

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 Employers By State in 2021.

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
CTSRMC Coordinator

Job Profile Title
Coordinator B

Job Description Summary
Reporting directly to the CTSRMC Manager, the Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator is responsible for coordination of the initial, ongoing and annual review of research protocols submitted to the CTSRMC for scientific merit, feasibility, disease relevance, prioritization, competitiveness and statistical design. This includes pre-reviewing submissions assigned to the convened CTSRMC for completeness and compliance with NCI, federal and institutional regulations/policies; pre-reviewing submissions eligible for expedited review and working with researchers and research staff to resolve issues related to convened or expedited review. He/she prepares meeting agendas; assigns scientifically appropriate protocols to CTSRMC members to review; attends convened meetings; and maintains thorough and complete notes on the discussion. He/she prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in or disapproving research, and a written summary of controverted issues and their resolution. The CTSRMC Coordinator prepares written correspondence to investigators of all CTSRMC actions and decisions. The CTSRMC Coordinator reviews claims of exemptions and expedited reviews as assigned and determines the appropriate level of review and assigns scientific or statistical reviewer as appropriate to the type of study. He/she is the main source of contact between CTSRMC Chairs, CTSRMC member/reviewers and investigators. He/she maintains minutes, CTSRMC rosters, CTSRMC electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and ACC SOPs. In contacts with investigators the CTSRMC Coordinator provides guidance on issues related to CTSRMC regulations and CTSRMC actions. The CTSRMC Coordinator participates, as assigned, in research community outreach and training activities; as well as CTSRMC member training and CTSRMC quality improvement initiatives including the review of existing CTSRMC policies and procedures. The CTSRMC Coordinator will interact directly with Penn's IRB to create harmonization of review of study protocols. Additionally, the CTSRMC Coordinator is responsible for maintaining a database of information related to CTSRMC activities and generating reports that are used by ACC leadership and the NCI.

POSITION IS CONTINGENT UPON FUNDING

Job Description

Reporting directly to the CTSRMC Manager, the Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator is responsible for coordination of the initial, ongoing and annual review of research protocols submitted to the CTSRMC for scientific merit, feasibility, disease relevance, prioritization, competitiveness and statistical design. This includes pre-reviewing submissions assigned to the convened CTSRMC for completeness and compliance with NCI, federal and institutional regulations/policies; pre-reviewing submissions eligible for expedited review and working with researchers and research staff to resolve issues related to convened or expedited review. He/she prepares meeting agendas; assigns scientifically appropriate protocols to CTSRMC members to review; attends convened meetings; and maintains thorough and complete notes on the discussion. He/she prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in or disapproving research, and a written summary of controverted issues and their resolution. The CTSRMC Coordinator prepares written correspondence to investigators of all CTSRMC actions and decisions. The CTSRMC Coordinator reviews claims of exemptions and expedited reviews as assigned and determines the appropriate level of review and assigns scientific or statistical reviewer as appropriate to the type of study. He/she is the main source of contact between CTSRMC Chairs, CTSRMC member/reviewers and investigators. He/she maintains minutes, CTSRMC rosters, CTSRMC electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and ACC SOPs. In contacts with investigators the CTSRMC Coordinator provides guidance on issues related to CTSRMC regulations and CTSRMC actions. The CTSRMC Coordinator participates, as assigned, in research community outreach and training activities; as well as CTSRMC member training and CTSRMC quality improvement initiatives including the review of existing CTSRMC policies and procedures. The CTSRMC Coordinator will interact directly with Penn's IRB to create harmonization of review of study protocols. Additionally, the CTSRMC Coordinator is responsible for maintaining a database of information related to CTSRMC activities and generating reports that are used by ACC leadership and the NCI.

POSITION CONTINGENT UPON FUNDING

Qualifications: Minimum of a BA/BS in a relevant discipline (biological sciences required and 3-5 years of experience and knowledge directly related to clinical research; detailed knowledge of applicable regulations related to clinical research or an equivalent combination of education and experience required.

Knowledge of IRB and/or scientific review in an academic cancer center is a plus. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; must be able to work in a face-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution.

This job description is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

NOTE: Re-location and/or Visa Sponsorship is not available for this position.

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.

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.




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

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/CTSRMC-Coordinator_JR00041002-1

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