Clinical Research Associate; CRA - Immunology-Remote

Job Description

Candidate must reside in one of the following locations:
Texas, Illinois, Arizona, Florida, California, NY, Colorado.

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA‑Manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Actively develops and expands the territory for clinical research, finding and developing new sites.

Participates in internal meetings and work streams as SME for monitoring processes and systems.

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH‑GCP, Sponsor SOPs, local laws & regulations, protocol, site monitoring plan and associated documents.
• Gain an in‑depth understanding of the study protocol and related procedures.
• Coordinate & manage various tasks in collaboration with other sponsor roles to achieve site ready.
• Participate & provide inputs on site selection and validation activities.
• Perform remote and on‑site monitoring & oversight activities using various tools to ensure:
  • Data generated at site are complete, accurate and unbiased.
  • Subjects’ rights, safety and well‑being are protected.
• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close‑out visits and record clear, comprehensive and accurate visit & non‑visit contact reports in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start‑up, study maintenance and study close‑out.
• Communicate with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalates per defined CRA escalation pathway as appropriate in collaboration with CRA‑Manager, CRM, TA Head and CRD.
• Work in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations and external vendors and IRB/IECs and regulatory authorities in support of assigned sites.
• Manage and maintain information and documentation in CTMS, eTMF and other systems as appropriate per timelines.
• Contribute to CRA team knowledge by acting as process SME, buddy/mentor and sharing best practices as appropriate.
• Support and/or lead audit/inspection activities as needed.
• Perform co‑monitoring visits where appropriate.
• Contribute to the identification of new potential sites and work closely with them to develop strong clinical research capabilities.

• Ability to travel domestically and internationally approximately 65‑75% of working time.
• Expected travelling 2‑3 days per week.
• Current driver’s license required.

• Fluent in local languages and English (verbal and written) with excellent communication skills.
• Good understanding of clinical research and GCP/ICH guidelines.
• Knowledge of global, country and regional clinical research guidelines.
• Hands‑on knowledge of Good Documentation Practices.
• Proven skills in site management including performance and recruitment.
• High level of monitoring skill with independent professional judgment.
• Good IT skills (MS Office, clinical IT applications on computer, tablet and mobile).
• Ability to understand and analyze data/metrics and act appropriately.
• Capability to manage complex issues in a solution‑oriented manner.
• Perform root cause analysis and implement preventative and corrective action.

• Effective time management, organizational and interpersonal skills, conflict management, problem‑solving skills.
• High sense of accountability/urgency; ability to set priorities and handle multiple…