Clinical Research CTMS Specialist (Remote)

 Posted 4 hours ago
     
 $75000 - $85000 per year
  
2-5 years experience
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AI Summary

The specialist is responsible for configuring new protocols in the CTMS system by translating clinical trial Schedules of Assessments into functional requirements. They also collaborate with subject matter experts to create and maintain supporting clinical documentation such as eligibility checklists and study schedules.

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. 


The START Center for Cancer Research is seeking a Clinical Research CTMS Specialist (Remote) who will ensure that new protocols are configured completely and accurately in the CTMS system, to support clinical teams in protocol execution and management. Specifically, this role will translate clinical trial Schedule of Assessments (SOE) - through conversations with subject matter experts - into functional requirements, specified in an appropriate level of detail that can be used for application configuration by the Clinical Trial Management Software (CTMS). This role is also responsible for working with the Subject Matter Experts (SMEs) and leadership to create, edit and confirm accuracy of supporting clinical documentation to include but not limited to:  Eligibility Checklists, Study Schedules, supporting assessment tools and other documents as identified.


This is a remote role. The salary range for this role is $75,000 - $85,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. 


Work Schedule:
Monday-Friday 8:00am-5:00pm


Essential Responsibilities

  • Serve as a liaison between the subject matter experts and the application core team to gather and communicate requirements which help define and verify application configuration.
  • Translate (As applicable) calendars created by outside teams into START-approved calendars, including language translation for Spanish sites if necessary.
  • Coordinates the activation of all new and legacy clinical trial calendar building and general study set up activities with internal and supporting external entities within the timeline parameters of Site Initiation Visits.
  • Using Oncore®/Excel ®/Word, develops study tools, including but not limited to eligibility checklists, calendars and schedules, C1D1 checklists, supporting assessment tools, PK and EKG flow sheets (as required) and other documents as identified in collaboration with the Research Nurse, Study Coordinator and/or Principal Investigator.
  • Updates pertinent Oncore Reviews data in a timely manner to facilitate Amendment receipt/approval, Consent /Re-Consent requirements and clinical trial status updates.
  • Build strong relationships with project leadership, subject matter experts, clinical application colleagues and financial budget team members.
  • Work with SMEs and project leadership to complete workflow decisions, workflow documentation, and supporting policies.
  • Ability to understand the organization’s strategic priorities and adapt project timelines and tasks accordingly.
  • Ability to escalate risks or issues effectively within the organization, if needed.
  • Ability to identify and manage scope changes during the course of a project.


Required Education and Experience: 

  • Bachelor's Degree with at least 2 years of experience in the clinical research industry, or equivalent education and experience
  • Demonstrate accountability in project ownership and solution-oriented work approach
  • Creative problem-solving skills; ability to navigate through complex Phase I Oncology Protocols and apply to START’s Mission of quality data collection
  • Proven organizational skills including attention to detail and multi-tasking skills
  • Excellent verbal and written communication skills
  • Strong working knowledge of Microsoft Excel, Word, and PowerPoint


Physical & Travel Requirements: 

  • Sitting for extended periods of time.
  • Typing and computer use for extended periods of time.


Best-in-Class Benefits and Perks

We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:

  • Comprehensive health coverage: Medical, dental, and vision insurance provided
  • Robust retirement planning: 401(k) plan available with employer matching
  • Financial security: Life and disability insurance for added protection
  • Flexible financial options: Health savings and flexible spending accounts offered
  • Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
  • Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.


More about The START Center for Cancer Research

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.


Learn more at STARTresearch.com.


Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.


We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.


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