"CTSRMC Coordinator C"

Job Description Summary

Reporting directly to the CTSRMC Manager, the Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator C 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.

Job Responsibilities

• Responsibilities of this position include pre-reviewing submissions assigned to the convened CTSRMC for completeness and compliance with NCI, federal and institutional regulations/policies and providing expert guidance to investigators and study teams to facilitate corrections to improve the quality of study documents including the protocol and ICF. Guidance will include but is not limited to: ensuring appropriate AE/SAE language is contained within the protocol based on the phase and type of study; ensuring Medical Monitoring and/or DSMBs sections are written in compliance with NIH guidelines; ensuring appropriate study monitoring or auditing is described; and that institutional protocols contain all required elements, clearly identify sponsorship roles and cancer center auditing; reviewing claims of exemption and expedited review submissions to determine the appropriate level of review and triaging submissions to the scientific, statistical reviewer and/or regulatory reviewer as appropriate to the type of study. These quality control steps must be performed within strict timelines to minimize any delays in time-to-activation. The CTSRMC Coordinator C plays a pivotal role in ensuring that only protocols of the highest quality move through to scientific peer review.
• The CTSRMC Coordinator C assists the manager with preparing meeting agendas; preparing documents for committee meetings including converting documents and posting them to a secure website; attends convened meetings and supports the manager by contacting members and investigators throughout the meeting to coordinate their arrival all while following a strictly timed agenda, maintains accurate and complete notes on attendance and all discussions. Reviews recorded minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in or disapproving research and the assigned priority score.
• The CTSRMC Coordinator C must effectively and professionally communicate verbally and in writing with investigators and study teams members related to all applicable CTSRMC actions.
• The CTSRMC Coordinator C is responsible for meticulous documentation of all CTSRMC-related activities following strict policies and procedures for file management, version control and naming conventions; real-time tracking in a custom database application of all work performed is essential to the documentation process.
• The CTSRMC Coordinator C participates in training activities for committee members, study teams and junior DOCM staff and actively participates in DOCM quality improvement initiatives.
• The CTSRMC Coordinator C will interact directly with Penn's IRB to harmonize the review of cancer-relevant study protocols.

Qualifications

Bachelor of Arts, Bachelor of Science, Bachelor of Fine Arts, and 3 to 5 years of experience or equivalent combination of education and experience are required. Preference is given to candidates with a BA/BS/BFA. Experience must be directly in the field of clinical research conduct or operations. Candidates without clinical research experience will not be considered. Experience with IRB and/or scientific review in an academic cancer center is a strong 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; must be comfortable using multiple databases to both find answers and create new data; support a culture of customer service and collaboration; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, be a problem solver and embrace a dynamic work environment. Must be able to establish trust and maintain positive working relationships at all levels of the institution.

All work will be performed independently with minimal supervision or direction; some work-related responsibilities may occur outside of regular business hours. This role requires the ability to travel between offices and to off-site locations (some over 30 miles from Philadelphia) where public transportation may not be available. Applicants must have reliable means to travel to these sites.

Position is contingent upon continued funding.

This job is not only about your technical skills; it's about how you lend your positivity and presence, combined with your skill set to an energized environment and highly collaborative team.

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

Fully remote work options are not available. This is a hybrid eligible position with a work week divided between working on-site multiple days a week in Philadelphia and working locally off-site.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$64,500.00 - $85,000.00 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, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements

Background checks may be 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

Equal Employment Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state, or local law.

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/CTSRMC-Coordinator-C_JR00111881