Clinical Research Associate (Remote)

Placements24

Willows (CA)

Hybrid

USD 90,000 - 130,000

Full time

3 days ago
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Benefits offered by this job

Healthcare coverage
Retirement savings plan
Generous annual leave and sick leave
Professional development and trainings
Fully remote work arrangement
Laptop and mobile phone provided
Travel expense reimbursement

Job summary

Placements24 is seeking a highly motivated Clinical Research Associate for a fully remote role in the United States. You will monitor trials, ensure GCP/ICH compliance, and act as a liaison between sites and the study team.

Responsibilities include site visits (virtual or on-site as needed), SDV and CRF reviews, issue resolution, and TMF maintenance. Travel may be required for hybrid elements and on-site visits.

Qualifications

  • Bachelor's degree in a life science, nursing, pharmacy, or related field.
  • Minimum 3 years of experience as a Clinical Research Associate in pharma or CRO.
  • Thorough understanding of ICH-GCP guidelines and regulatory requirements.
  • Proven experience monitoring clinical trials across various therapeutic areas.
  • Excellent SDV skills and attention to detail in data review.
  • Strong organizational, communication, and interpersonal skills.
  • Ability to work independently, travel as required (hybrid elements possible).
  • Proficiency in CTMS and EDC systems.

Responsibilities

  • Monitor assigned clinical trial sites to ensure compliance with protocol, GCP, and regulatory requirements.
  • Conduct pre-study, initiation, interim, and close-out visits (remote or on-site as needed).
  • Verify accuracy, completeness, and consistency of data through SDV and CRF review.
  • Manage and resolve site-related issues, escalating as necessary to the Clinical Trial Manager.
  • Ensure timely submission of all trial documentation and reports.
  • Train and mentor investigators and site staff on study procedures and data collection.
  • Manage drug accountability and investigational product supplies at study sites.
  • Facilitate communication between investigators, study coordinators, and internal teams.
  • Maintain updated TMF documentation.
  • Participate in study team meetings and provide updates on site performance.

Skills

SDV skills
Attention to detail
Organizational skills
Communication skills
Interpersonal skills

Education

Bachelor's degree in life sciences / nursing / pharmacy or related field

Tools

CTMS
EDC systems

Job description

About the Role

Our client, a dynamic and growing pharmaceutical company focused on innovative treatments, is seeking a highly motivated and experienced Clinical Research Associate (CRA) to join their fully remote clinical operations team. This position is critical for overseeing the successful execution of clinical trials, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. As a remote CRA, you will conduct site visits (virtual or on-site as required), monitor trial progress, manage data integrity, and serve as the primary liaison between investigational sites and the study team. We foster a remote-first culture, providing robust support systems, advanced technological tools, and a collaborative environment to enable our team members to thrive professionally while maintaining excellent work-life integration. Your expertise will directly contribute to bringing life-changing therapies to patients worldwide.

Key Responsibilities
  • Monitor assigned clinical trial sites to ensure compliance with protocol, GCP, and regulatory requirements.
  • Conduct pre-study, initiation, interim, and close-out visits (potentially remotely or on-site as dictated by study needs).
  • Verify accuracy, completeness, and consistency of data through source data verification (SDV) and review of Case Report Forms (CRFs).
  • Manage and resolve site-related issues, escalating as necessary to the Clinical Trial Manager.
  • Ensure timely submission of all required trial documentation and reports.
  • Train and mentor investigators and site staff on study procedures and data collection.
  • Manage drug accountability and investigational product supplies at study sites.
  • Facilitate communication between investigators, study coordinators, and internal study teams.
  • Maintain updated Trial Master File (TMF) documentation.
  • Participate in study team meetings and provide regular updates on site performance.
Requirements
  • Bachelor's degree in a life science, nursing, pharmacy, or related field.
  • Minimum of 3 years of experience as a Clinical Research Associate in the pharmaceutical or CRO industry.
  • Thorough understanding of ICH-GCP guidelines and regulatory requirements.
  • Proven experience in monitoring clinical trials across various therapeutic areas.
  • Excellent SDV skills and attention to detail in data review.
  • Strong organizational, communication, and interpersonal skills.
  • Ability to work independently, manage time effectively, and travel as required (if applicable for hybrid elements).
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Must have a dedicated home office space conducive to remote work.
  • Adaptability and a proactive approach to problem-solving in a remote setting.
Benefits
  • Competitive annual salary of ZAR.
  • Comprehensive healthcare coverage, including medical, dental, and vision.
  • Retirement savings plan options.
  • Generous annual leave and sick leave allowance.
  • Opportunities for professional development, training, and certifications.
  • Fully remote work arrangement, fostering flexibility and work-life balance.
  • Company-provided laptop and mobile phone.
  • Travel expense reimbursement when on-site visits are required.
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