CRA II/Sr CRA – Multiple Therapeutic Areas

This is a fully remote position, open to applicants in Florida.

📋 Description

• Execute and coordinate activities related to clinical monitoring and site management.

• Conduct both remote and on-site visits to evaluate adherence to protocol and regulatory standards.

• Oversee necessary clinical trial documentation and sponsor-specific protocols.

• Ensure trials align with approved protocols, ICH-GCP guidelines, regulations, and standard operating procedures (SOPs).

• Safeguard the rights, welfare, and data integrity of trial subjects.

• Maintain audit readiness and foster collaborative relationships with investigational sites.

• Monitor investigator sites by employing a risk-based monitoring strategy.

• Conduct root cause analyses, identify corrective and preventive measures, and address site deficiencies.

• Ensure data accuracy through reviewing source documents, verifying source data, and examining case report forms (CRFs).

• Evaluate investigational products through inventory assessments and record reviews.

• Prepare monitoring reports and correspondence; escalate and track issues until resolution.

• Maintain ongoing communication with investigative sites between monitoring visits.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and provide recommendations regarding site eligibility.

• Conduct trial closeout activities and retrieve trial materials.

• Ensure completeness of essential documents and perform on-site file reviews.

• Provide trial status and progress updates to the Clinical Team Manager.

• Update clinical trial management systems as necessary.

• Facilitate communication among investigative sites, client organizations, and the project team.

• Address requests from the company, clients, and regulatory bodies during audits and inspections.

• Complete expense reports and timesheets accurately.

• Assist with project publications and tools, contributing to initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences discipline, or Registered Nursing certification, or equivalent formal academic/vocational qualification.

• Approximately 1 year of experience as a clinical research monitor, or successful completion of the PPD Drug Development Fellowship.

• Consideration may be given to the equivalency of relevant education, training, and/or directly related experience.

• Valid driver's license as required.

• Demonstrated clinical monitoring competencies.

• Familiarity with medical/therapeutic areas and medical terminology.

• Working knowledge of ICH GCPs, applicable regulations, and procedural documents.

• Understanding of Risk-Based Monitoring concepts and methodologies.

• Strong critical thinking, root cause analysis, and problem-solving abilities.

• Effective oral and written communication capabilities.

• Strong organizational and time management skills.

• Interpersonal skills with a keen attention to detail.

• Ability to work flexibly and adaptively in various situations.

• Capability to work independently or collaboratively as part of a team.

• Proficient in Microsoft Office and quick to learn relevant software.

• Good command of the English language and grammar.

• Strong presentation skills.

• Willingness and ability to travel frequently, generally 60–80%, including potential extended overnight stays.

🏝️ Benefits

• Fully remote work arrangement.

• Coverage of travel expenses incurred due to required site visits.

• Provision of personal protective equipment such as eyewear, garments, and gloves.