Freelance Regional Clinical Trial Coordinator

Posted Yesterday
Be an Early Applicant
4 Locations
Remote
Junior
Biotech
The Role
Provide remote trial documentation and TMF/CPF management support, upload site and country documents to Veeva Vault, prepare ISFs and submission packages, assist CRAs and Trial Manager with data entry, meeting minutes, tracking, stakeholder communication, and support audits/inspections.
Summary Generated by Built In

Rho, an award-winning, stable, full-service CRO known for its collaborative, dynamic culture based in the US, is quickly expanding their presence in Europe. We are a thriving company, and we will deliver global full-service clinical development services and unmatched customer support – worldwide.

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we believe in the power of passionate individuals working together to make a difference in clinical research.

We are seeking a Freelance Regional Clinical Trial Coordinator to join us - this will be a full time (150 hours per month) freelance role. This is a home based position.

Responsibilities:

  • Supports in preparation of ISFs (Investigator Site Files).
  • Contact, communication and guidance to CRA and sites as instructed by Trial manager
  • Maintenance of TMF (Trial Master File) or the CRO Project File and periodically review the TMF and/or CPF to ensure accuracy, completeness.
  • Upload Country and Site level documents in Veeva Vault  in a timely manner.
  • Timely transfer of Study documents (scanned copies) to Sponsor, as agreed, on an ongoing basis.
  • Supports in preparation of documents package for submission to CA (Competent Authorities) and EC (Ethics Committee), and support for EU CTR submissions
  • Facilitate the communication between stakeholders in regards to documentation management
  • Provide support to stakeholders on the planning, collecting, filing, confirming, archiving of trial records, as needed
  • Support the stakeholders to confirm records availability at specific timepoints, as required by Sponsor procedures
  • Sponsor/ Rho team meetings preparation, drafting meeting minutes.
  • Maintains tracking information for Study activities.
  • Support Trial Manager on data entry and maintenance to systems (includes correction of wrong data entry)
  • Supports CRA (Clinical Research Associate) in maintaining ISF at Site.
  • Support sites getting access to systems, as needed
  • Support Trial Manager sharing updates with sites
  • Support on audits and/or inspections

Requirements
  • Experience in clinical trial coordination or related administrative roles.
  • English language
  • Computer literacy
  • Preferably university degree in position related field
  • Advanced knowledge of ICH-GCP guidelines
  • Excellent communication (including reading, verbal, and written in both local language and English) and organizational skills
  • Capabilities in managing multiple assignments and work independently

Please submit your CV/resume in English.

Skills Required

  • Experience in clinical trial coordination or related administrative roles
  • English language proficiency
  • Computer literacy
  • University degree in a position-related field
  • Advanced knowledge of ICH-GCP guidelines
  • Excellent communication and organizational skills (local language and English)
  • Ability to manage multiple assignments and work independently
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The Company
HQ: Durham, North Carolina
793 Employees
Year Founded: 1984

What We Do

Changing what it means to work with a global CRO. At Rho, we believe expertise is everything. With team members spanning continents, we bring together the brightest minds in the industry. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. Sparked by a shared mission to improve lives, our experts take clients beyond procedural operations and into truly proactive problem-solving. Through a collaborative approach and individualized attention, our focus is advancing your program so that, together, we can help heal the world. That is what drives us. Experience, Rho.

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