Senior Clinical Research Associate

This is a fully remote position, open to applicants in Florida, +3 more states.

📋 Description

• Execute and oversee clinical trials to ensure compliance with sponsor and investigator responsibilities, as well as adherence to local regulatory standards and ICH GCP guidelines.

• Evaluate potential investigative sites, initiate trial processes, instruct site personnel, and conclude trials at investigative locations.

• Conduct site startup activities, which include collecting regulatory documents, reviewing informed consent, supporting IRB/IEC submissions, and negotiating budgets and contracts.

• Review and verify clinical trial data collected either onsite or remotely.

• Provide consistent updates on site status and maintain trial management tools.

• Complete monitoring activity documentation in accordance with sponsor SOPs.

• Collaborate with clinical team members to address trial and clinical issues.

• Escalate site and trial concerns as per sponsor SOPs.

• Conduct essential document site file reconciliation.

• Perform source document verification and resolve queries.

• Evaluate investigational product accountability, dispensation, and compliance.

• Confirm serious adverse event reporting aligns with trial specifications and ICH GCP guidelines.

• Communicate effectively with investigative sites and update tracking systems accordingly.

• Ensure necessary training is completed and properly documented.

• Operate with minimal oversight at the senior level.

• Act as a subject matter expert for clinical operations monitoring activities.

• Provide leadership for assigned clinical operations projects.

• Lead observation and performance visits.

• Collaborate with other functional areas to resolve site issues and facilitate trial timelines.

⛳️ Requirements

• A bachelor's degree or equivalent in a clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (e.g., registered nurse) or comparable work experience is required.

• 2-5 years of clinical monitoring experience required (CRA 2 for sponsor).

• 5+ years of clinical monitoring experience required (Sr CRA for sponsor).

• Familiarity with ICH and local regulatory authority regulations pertaining to drug development.

• Proficient in reading, writing, and speaking fluent English.

• Oncology monitoring experience at II/III level is required.

• Experience in feasibility/site selection/site startup is mandatory.

• Budget negotiation experience is preferred.

• Must be legally authorized to work in the United States and will not require sponsorship for employment visa status now or in the future.

• Employment with ICON is contingent upon possessing the legal right to work in the country where the role is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.