Senior Clinical Research Associate – FSP

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

📋 Description

• Execute and coordinate clinical monitoring as well as site-management activities.

• Perform both remote and on-site visits to evaluate compliance with protocols and regulations.

• Oversee sponsor procedures, guidelines, documentation, and monitoring settings.

• Guarantee that trials adhere to approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

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

• Monitor investigator sites using risk-based strategies, including RCA, SDR, SDV, and CRF review.

• Evaluate the inventory and records of investigational products.

• Record observations, escalate deficiencies, and ensure issues are resolved.

• Keep in contact with investigative sites between monitoring visits.

• Track trial progress and provide updates to the Clinical Team Manager.

• Update clinical trial systems and conduct necessary CTMS report quality checks.

• Participate in investigator meetings and identify qualified investigators and sites.

• Initiate sites, ensure trial closure, and retrieve trial materials.

• Verify that essential documents are complete and conduct on-site file reviews.

• Assist with project publications, tools, team calls, and other CTM-assigned study tasks.

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

• Address company, client, and regulatory audits and inspections.

• Complete expense reports, timesheets, and other administrative duties.

• Contribute to project work and initiatives for process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or an equivalent relevant formal academic/vocational qualification.

• At least 3 years of on-site clinical monitoring experience.

• Preferred experience in infectious disease (pneumonia) and ophthalmology clinical studies.

• Proficient clinical monitoring skills.

• Understanding of medical/therapeutic area knowledge and medical terminology.

• Knowledge and demonstrated application of ICH GCPs, relevant regulations, and procedural documents.

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

• Capability to manage Risk Based Monitoring concepts and processes.

• Strong oral and written communication skills with medical professionals.

• Customer-focused with good listening skills, attention to detail, and the ability to identify underlying issues.

• Excellent interpersonal, organizational, and time management skills.

• Ability to work flexibly, adaptively, independently, and as part of a team.

• Proficient in Microsoft Office and capable of learning relevant software.

• Strong English language skills and grammar proficiency.

• Good presentation skills.

• Ability to comply with sponsor/client/site requirements, which may include vaccination-status or personal-information disclosures.

• Willingness to travel frequently, typically 60–80%, including frequent driving and potential extended overnight stays.

• Ability to work in office, laboratory, clinical, and/or home-office settings while using necessary personal protective equipment.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.