"CTSRMC Coordinator C"

CTSRMC Coordinator 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. 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

CTSRMC Coordinator C

Job Profile Title

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 Description

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.

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