Clinical Trials Coordinator

3 weeks ago

Philadelphia, Pennsylvania, United States University of Pennsylvania Full time
Job Summary

We are seeking a highly organized and detail-oriented Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator to join our team at the University of Pennsylvania. The successful candidate will be responsible for coordinating the initial, ongoing, and annual review of research protocols submitted to the CTSRMC for scientific merit, feasibility, disease relevance, prioritization, competitiveness, and statistical design.

Key Responsibilities
  • Pre-review submissions assigned to the convened CTSRMC for completeness and compliance with NCI, federal, and institutional regulations/policies.
  • Pre-review submissions eligible for expedited review and work with researchers and research staff to resolve issues related to convened or expedited review.
  • Prepare meeting agendas, assign scientifically appropriate protocols to CTSRMC members to review, attend convened meetings, and maintain thorough and complete notes on the discussion.
  • Prepare 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.
  • Prepare written correspondence to investigators of all CTSRMC actions and decisions.
  • Review claims of exemptions and expedited reviews as assigned and determine the appropriate level of review and assign scientific or statistical reviewer as appropriate to the type of study.
  • Maintain minutes, CTSRMC rosters, CTSRMC electronic files, and all other required regulatory documents in compliance with federal regulations, institutional policies, and ACC SOPs.
  • Interact directly with Penn's IRB to create harmonization of review of study protocols.
  • Participate 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.
Requirements
  • Minimum of a BA/BS in a relevant discipline, biological sciences, and 3-5 years of experience or an equivalent combination of education and experience required.
  • Knowledge directly related to clinical research preferred.
  • Detailed knowledge of applicable regulations related to clinical research.
  • Experience with 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, and the ability to work in a fast-paced environment with time-sensitive deadlines and competing priorities.
What We Offer

The University of Pennsylvania offers a competitive benefits package, including 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.

This is a hybrid eligible position, with a work week divided between working onsite and working remotely.

The University of Pennsylvania is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and welcoming environment for all employees.

  • Clinical Trials Coordinator

    2 weeks ago

    Philadelphia, Pennsylvania, United States University of Pennsylvania Full time

    Job Title: CTSRMC CoordinatorThe University of Pennsylvania seeks a highly skilled and detail-oriented CTSRMC Coordinator to join our team. As a key member of our Clinical Trials Scientific Review and Monitoring (CTSRMC) team, you will play a critical role in ensuring the integrity and quality of our clinical trials.Key Responsibilities:Coordinate the...

  • Clinical Trials Proposal Coordinator

    1 week ago

    Philadelphia, Pennsylvania, United States PSI CRO Full time

    Job Title: Clinical Trials Proposal ManagerAt PSI CRO, we are seeking a highly skilled Clinical Trials Proposal Manager to join our team. As a key member of our proposal development team, you will play a critical role in coordinating all phases of our proposal process, ensuring that we maintain our high win rate of 30% and above.You will work closely with...

  • Clinical Trials Project Manager

    1 week ago

    Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full time

    Job SummaryThe Sr. Clinical Trial Project Manager position is a key role within the Center for Cellular Immunotherapies Clinical Operations Team. The primary mission of the Clinical Operations Team is to manage and optimize the clinical research infrastructure necessary for bringing novel/personalized cell and gene therapies to patients.Key ObjectivesSupport...

  • Senior Clinical Trial Project Manager

    4 weeks ago

    Philadelphia, Pennsylvania, United States Perelman School of Medicine University of Pennsylvania Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Trial Project Manager to join our team at the Perelman School of Medicine University of Pennsylvania. As a key member of our clinical trials team, you will be responsible for managing clinical projects and programs, ensuring timely delivery of high-quality results.Key ResponsibilitiesDevelop and...

  • Clinical Trials Manager

    2 weeks ago

    Philadelphia, Pennsylvania, United States Temple Health Full time

    Job Title: Clinical Trials ManagerTemple Health is seeking a highly skilled Clinical Trials Manager to join our team. As a key member of our Clinical Research Contracting department, you will be responsible for overseeing the Medicare Coverage Analysis process for all clinical trials types.Key Responsibilities:Supervise Coverage Analysts in creating Medicare...

  • Clinical Trials Comparator Sourcing Specialist

    12 hours ago

    Philadelphia, Pennsylvania, United States Verbatim Pharma Full time

    {"title": "Clinical Trials Comparator Sourcing Manager", "description": "We are seeking a highly skilled Clinical Trials Comparator Sourcing Manager to join our team at Verbatim Pharma. As a key member of our clinical trials supply chain, you will be responsible for managing end-to-end comparator supply projects, ensuring timely and successful delivery. Your...

  • Clinical Trials Comparator Sourcing Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Verbatim Pharma Full time

    Exciting Opportunity: Clinical Trials Comparator Sourcing ManagerWe are seeking a highly experienced Clinical Trials Comparator Sourcing Manager to join our growing team at Verbatim Pharma. As a key member of our clinical trials supply chain team, you will be responsible for managing end-to-end comparator supply projects, ensuring timely and successful...

  • Clinical Trials Proposal Manager

    3 weeks ago

    Philadelphia, Pennsylvania, United States PSI CRO Full time

    Job Title: Clinical Trials Proposal ManagerWe are seeking a highly skilled Clinical Trials Proposal Manager to join our team at PSI CRO. As a key member of our proposal development team, you will play a critical role in coordinating all phases of our proposal process, ensuring timely delivery and high-quality results.Key Responsibilities:Develop high-quality...

  • Clinical Trials Project Manager

    1 week ago

    Philadelphia, Pennsylvania, United States University of Pennsylvania Full time

    Job Title: Sr. Clinical Trial Project ManagerJoin the University of Pennsylvania's Perelman School of Medicine as a Sr. Clinical Trial Project Manager and play a critical role in accelerating and synergizing efforts that can quickly transition fundamental immunobiology research into the clinic.About the Role:The Sr. Clinical Trials Project Manager will work...

  • Clinical Trial Disclosure Director

    3 weeks ago

    Philadelphia, Pennsylvania, United States Jobs for Humanity Full time

    Job DescriptionJob Title: Clinical Trial Disclosure DirectorJob Summary:The Clinical Trial Disclosure Director will oversee the preparation and submission of clinical trial data to regulatory agencies and public registries. This role will be responsible for ensuring compliance with global regulations and company policies related to clinical trial...

  • Senior Clinical Trial Project Manager

    3 weeks ago

    Philadelphia, Pennsylvania, United States Perelman School of Medicine University of Pennsylvania Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Trial Project Manager to join our team at the Perelman School of Medicine University of Pennsylvania. As a key member of our clinical trials team, you will be responsible for managing clinical projects/programs, including deliverables from all functional areas and vendors in accordance with...

  • Clinical Trials Manager

    3 weeks ago

    Philadelphia, Pennsylvania, United States Temple University Full time

    Job SummaryThe Manager of Medicare Coverage Analysis ('MCA') plays a critical role in ensuring compliance with FDA regulations and Medicare guidelines. This position is responsible for supervising Coverage Analysts, conducting Medicare Coverage Analysis, and reviewing invoices/billing for clinical trials.Key ResponsibilitiesSupervise Coverage Analysts in...

  • Clinical Research Coordinator

    2 weeks ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job Title: Clinical Research CoordinatorWe are seeking a highly motivated and organized Clinical Research Coordinator to join our team at the University of Pennsylvania Department of Cardiac Surgery. The successful candidate will be responsible for assisting in the conduct of NHLBI-sponsored clinical trials as part of the Cardiothoracic Clinical Trials...

  • Clinical Research Coordinator

    3 weeks ago

    Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full time

    Job SummaryThis position is responsible for coordinating clinical trials and research studies in the Cardiac Electrophysiology Department. The successful candidate will assist in the management of multiple clinical trials, coordinate study protocols, and ensure compliance with good clinical practice.Key ResponsibilitiesManage multiple clinical trials and...

  • Clinical Research Coordinator

    4 weeks ago

    Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full time

    Job SummaryThis position is a key member of the Cardiac Electrophysiology Department, responsible for managing multiple clinical trials and coordinating research studies. The successful candidate will have a strong background in research and clinical study methodologies, with excellent organizational and communication skills.Key ResponsibilitiesAssist in the...

  • Clinical Research Coordinator

    2 weeks ago

    Philadelphia, Pennsylvania, United States Perelman School of Medicine University of Pennsylvania Full time

    Job DescriptionJob Title: Clinical Research CoordinatorJob Summary: We are seeking a highly motivated and organized Clinical Research Coordinator to join our team at the Perelman School of Medicine University of Pennsylvania. The successful candidate will be responsible for coordinating clinical trials, managing study data, and ensuring compliance with...

  • Clinical Trial Disclosure Director

    6 days ago

    Philadelphia, Pennsylvania, United States Jobs for Humanity Full time

    Job DescriptionThe Medical Writing & Disclosure Department of Jobs for Humanity prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will...

  • Travel Clinical Research Coordinator, RN

    1 month ago

    Philadelphia, Pennsylvania, United States Care Access Full time

    Job SummaryCare Access is seeking a highly motivated and experienced Travel Clinical Research Coordinator, RN to join our team. As a Travel Clinical Research Coordinator, RN, you will be responsible for conducting clinical research studies in various locations across the United States. You will work closely with our team to execute study protocols, ensure...

  • Clinical Research Coordinator

    4 weeks ago

    Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full time

    Job SummaryWe are seeking a highly motivated and organized Clinical Research Coordinator to join our team in the Cardiac Electrophysiology Department. The successful candidate will be responsible for managing multiple clinical trials, coordinating study activities, and ensuring compliance with regulatory guidelines.Key ResponsibilitiesManage multiple...

  • Clinical Research Coordinator

    2 weeks ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Clinical Research Coordinator Job DescriptionJob Summary: We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team. The successful candidate will be responsible for the execution of all clinical trial aspects from start to finish, including implementation of clinical protocol requirements, patient support, and...