CovarsaDx

Clinical Trials Associate

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  • Job Title: Clinical Trials Associate
  • Location: Remote
  • Department: Clinical Operations
  • Reports To: Sr. Director of Clinical Operations & Regulatory Strategist
  • Job Type: Full-time
  • Salary Range: $60,000 – $75,000. Compensation offered will reflect the skills and experience of the candidate.
  • Classification: Exempt
  • To Apply: Submit resume and cover letter to Human Resources at hr@covarsadx.com.

Position Description

The Clinical Trial Associate will play a key role in supporting clinical trial operations by assisting with monitoring and supporting the Clinical Research Associates with studies. This role requires strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment. The ideal candidate will have experience in clinical research, healthcare, or logistics, with a proactive approach to problem-solving and process improvement.

Key Responsibilities

  • Support lead study CRA in the management and execution of studies
  • Work with lead study CRA to perform remote site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. These tasks include:
  • Perform study monitoring to include site regulatory documents, consent forms and source data verification of data included on case report forms.
  • Assist with document collection for trial master files.
  • Order, track and manage investigational product at sites. 
  • Write site contact reports and monitoring reports for study communication and visits.
  • Ensure compliance with SOPs and regulations including FDA, ICH and GCP guidelines.
  • Other tasks and responsibilities as required.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
  • Travel on a limited basis and at short notice to sites for monitoring visits.
  • Provide clinical administrative support and other projects operating under CovarsaDx Canada and ZoaDx as directed.

Additional Responsibilities

This job description is intended to outline the primary responsibilities of the Clinical Trials Associate; however, additional duties and tasks may be assigned as needed to support the clinical trial process. These additional responsibilities are not limited to the above and may evolve over time based on the requirements of the study or operational needs.

Education / Experience Requirements

  • Bachelor’s degree with relevant clinical research experience.
  • Two (2) years of experience in clinical research or clinical trial management is preferred.

Competencies

  • Communication and Interpersonal Skills – Ability to communicate effectively (written and verbal) with study teams, participants, and external stakeholders.
  • Time and Prioritization Management – Strong organizational skills, with ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
  • Attention to Detail – Excellent attention to detail and the ability to keep detailed, accurate records and ensure all protocol requirements and regulations are strictly followed.
  • Collaboration and Cross-Functional Coordination – Able to work with various groups to support documentation needs and ensure alignment across teams.
  • Operational Efficiency – Strong time management skills, able to use time productively to ensure high levels of operational efficiency and effectiveness.
  • Confidentiality – Able to maintain strict confidentiality in handling sensitive participant data and study-related information.
  • Technical Proficiency – Competence using common business software such as MSOffice (Word, Excel, PowerPoint, Outlook, Teams) and Adobe Acrobat and study-specific tools or software.
  • Knowledge of laboratory procedures and equipment.
  • Must possess analytical and creative thinking skills.

Work Environment / Physical Demands

  • Home-based office position with working conditions suitable and conducive to and efficient working environment.
  • Appropriate availability consistent with established practices and norms; effort may exceed 40 hours per week when required to meet critical deadlines.
  • Travel up to 10% by conventional means including aircraft, motor vehicles, etc., including overnight stays as needed.
  • Ability to sit and/or stand to work at a computer for extended periods of time.
  • Ability to lift and move up to 10 pounds.

Featured Benefits:

  • Medical, Dental, Vision insurance
  • Life/Short- and Long-Term Disability
  • 401K Plan and company match
  • PTO, Sick and Holiday Pay
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