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Clinical Trial Assistant @Orcabiosystems

[Hiring] Clinical Trial Assistant @Orcabiosystems

Apr 01, 2025 - Orcabiosystems is hiring a remote Clinical Trial Assistant. 💸 Salary: unspecified. 📍Location: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

Orca Bio is seeking an organized and proactive Clinical Trial Assistant (CTA) to support our clinical trial operations. This role will involve working closely with clinical research teams to ensure sites are prepared for visits, maintain data quality, and facilitate effective communication and follow-up on action items. The ideal candidate will collaborate cross-functionally with clinical operations and data management teams and ensure seamless post-visit updates in our clinical trial management systems (CTMS).

  • Assist site CRAs in preparing for site visits and ensure sites are ready for monitoring.
  • Support sites in maintaining high-quality data entry and tracking progress.
  • Collaborate with data management to identify key areas of focus for sites and CRAs.
  • Update CTMS and other relevant systems post-site visits, logging necessary data, including deviations and visit details.
  • Ensure accurate and timely updates to all relevant trial documentation.
  • Conduct follow-up on action items from site visits to ensure timely resolution and completion.
  • Manage site management calls, generate minutes, and provide updates on outstanding items.
  • Assist in compiling baseline information for progress reports.
  • Maintain and update various clinical trial systems, databases, study trackers, and documentation.
  • Support the set up and maintenance of the trial master file (TMF).
  • Assist with the preparation and submission of clinical trial-related materials as needed.

Qualifications

  • Previous experience as an in-house CTA CRA or equivalent clinical trial support role is required.
  • Prior experience as a CRCRA is preferred but not mandatory.
  • Strong organizational and critical thinking skills.
  • Ability to work independently and take initiative with minimal supervision.
  • Ability to quickly understand and apply instructions from the Clinical Trial Manager (CTM).
  • Willingness to participate in occasional site monitoring visits (virtual or in-person, approximately every quarter other month).
  • Excellent communication skills for effective coordination and follow-up with sites and internal teams.
  • Experience with CTMS and other clinical trial management systems and TMF systems is a plus.
  • Experience in Hematology/Oncology (HemOnc) or cell therapies is desired but not required.

Attributes

  • Self-motivated and capable of working independently with minimal supervision.
  • Efficient and detail-oriented in managing administrative tasks.
  • Proactive and adaptable with the ability to hit the ground running.

Company Description

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

  • We live by our core values of passion, courage, and integrity.
  • Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
  • We innovate on a path that hasn’t been paved.
  • We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
  • We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
  • We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

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Back to Remote jobs  >   All others
Clinical Trial Assistant @Orcabiosystems
All others
Salary 💸 unspecified
Remote Location
USA
Job Type full-time
Posted Apr 01, 2025
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📍 Be aware of the location restriction for this remote position: USA
Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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