CRA/Sr CRA - Client decicated (FSP)

Role overview

Monitoring and site management

• Monitor investigator sites using a risk-based approach and identify process failures, risks, and corrective or preventive actions.
• Review source data, source data verification, and case report forms as applicable to ensure data accuracy during on-site and remote monitoring.
• Assess investigational products through physical inventory and records review.
• Document observations in reports and letters using approved business writing standards; escalate deficiencies and follow issues through resolution.
• Maintain contact with investigative sites between visits to confirm protocol adherence, issue resolution, and timely data recording.
• Conduct monitoring tasks according to the approved monitoring plan and participate in investigator payment processes.
• Share responsibility with project team members for resolving findings and investigate and follow up on findings.

Trial coordination and documentation

• Participate in investigator meetings and identify potential investigators with the client company.
• Initiate trial sites according to procedures and recommend actions to support protocol, regulatory, and ICH-GCP compliance.
• Conduct trial closeout and retrieve trial materials.
• Ensure essential documents are complete and conduct on-site file reviews according to project specifications.
• Track trial status, report progress to the Clinical Team Manager, and update study systems according to agreed conventions.
• Facilitate communication among investigative sites, the client company, and the project team.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete expense reports and timesheets in a timely manner.
• Assist with project publications and tools, share ideas, and contribute to process-improvement initiatives.

Education and experience

• Bachelor's degree in a life-sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
• Previous experience comparable to one year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• An equivalent combination of appropriate education, training, and directly related experience may be considered.

Knowledge and skills

• Proven clinical monitoring skills.
• Understanding of medical or therapeutic-area knowledge and medical terminology.
• Ability to attain and maintain working knowledge of ICH-GCP guidelines, applicable regulations, and procedural documents.
• Critical thinking and problem-solving skills.