Clinical Research Associate

Robarts Clinical Trials - Atlanta, GA

Full-time
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Position Title: Clinical Research Associate (full-time, permanent)

Position Location: Remote-based (TX, OK, AR, LA, MS, KY, TN, AL, FL, GA, SC, NC, VA, WV, MD, DE)

Reports To (title): Manager, Monitoring & Site Management

Department/Unit: Monitoring & Site Management

Job Summary:
Performs and coordinates all aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting source data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and close out visits at investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.

Role and Responsibilities:
1. Investigational Site Monitoring

Conducts and documents site initiation, routine monitoring and close out visits, reviewing files, forms and filings to ensure alignment with SOPs, study guidelines and GCP best practices.
Work with site staff to verify CRF data are consistent with patient clinical source documents.
Monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events and other data management activities throughout the trial.
2. Site Recruitment and Set-up

Conducts and documents site initiation, routine monitoring and close out visits, reviewing files, forms and filings to ensure alignment with SOPs, study guidelines and GCP best practices.
Work with site staff to verify CRF data are consistent with patient clinical source documents.
Monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events and other data management activities throughout the trial.
3. Investigational Site Liaison

Primary clinical site contact for any questions or issues that arise from investigational sites.
Ensure all site related issues are followed until resolution.
Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project life-cycle.
4. Project Monitoring Lead

May be required to act as lead CRA on small, local or single modality projects, providing peer training, contributing to the design of monitoring plans, tools, documents, CRFs and protocols as requested.
Participate and/or present at study team, kickoff and investigator meetings, monitor site budget adherence and act as primary contact to sponsors for all monitoring related issues.

Qualifications:
Applicants should have a minimum of 2 years of related experience, as well as a minimum of a three year college advance diploma/degree in a relevant field of study preferably in Health/Life Sciences, or Nursing. SoCRA, CCRA and/or ACRP certification/designation is an asset. The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results. Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.

Working Conditions

Remote-based

Significant travel

  • Accommodations for job applicants with disabilities are available upon request