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Senior Clinical Research Associate (CRA) - Remote

Posted 40 weeks ago
All others
Full Time
USA

Overview

In this Senior CRA role, you will be responsible for monitoring the progress of both our early and late phase clinical studies, primarily our phase 3 Precision-T study, either at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

In Short

  • Monitor clinical studies at investigative sites or remotely.
  • Ensure compliance with protocols and regulatory requirements.
  • Conduct site visits approximately once a week.
  • Work with both early and late phase clinical studies.
  • Focus on the phase 3 Precision-T study.
  • Collaborate with investigative sites.
  • Maintain high standards of clinical trial conduct.
  • Document and report findings accurately.
  • Travel to sites that do not permit virtual monitoring.
  • Be part of a biotechnology company redefining transplant processes.

Requirements

  • Experience in clinical research monitoring.
  • Knowledge of ICH-GCP guidelines.
  • Familiarity with SOPs and regulatory requirements.
  • Ability to travel for site visits.
  • Strong communication skills.
  • Detail-oriented and organized.
  • Ability to work independently and remotely.
  • Background in biotechnology or related field.
  • Experience with phase 3 clinical trials preferred.
  • Proven track record in clinical trial management.

Benefits

  • Opportunity to work in a cutting-edge biotechnology company.
  • Impactful work in the field of blood cancer treatment.
  • Flexible working environment.
  • Collaborative team culture.
  • Professional development opportunities.
  • Competitive salary and benefits package.
  • Work with innovative cell therapies.
  • Contribute to improving patient survival rates.
  • Engage in meaningful clinical research.
  • Supportive work environment.
Orca Bio logo

Orca Bio

Orca Bio is a late-stage biotechnology company dedicated to transforming the transplant process for patients battling blood cancer. With a focus on developing next-generation cell therapies, Orca Bio aims to significantly improve survival rates while minimizing risks associated with traditional allogeneic stem cell transplants. The company is driven by a passion for science and a commitment to patient care, operating with core values of passion, courage, and integrity. Emphasizing innovation and a start-up culture, Orca Bio fosters an environment of collaboration and leadership, striving to make their advanced treatments accessible to all who need them.

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