Senior Clinical Research Associate, FSP

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

📋 Description

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

• Perform remote and on-site visits to evaluate adherence to protocols and regulatory standards.

• Oversee essential clinical trial documentation and sponsor or monitoring-environment protocols.

• Ensure that trials are conducted in accordance with approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Maintain readiness for audits and foster collaborative relationships with investigational sites.

• Utilize a risk-based monitoring approach to oversee investigator sites.

• Implement root cause analysis, critical thinking, and problem-solving strategies to pinpoint site-process failures and corrective/preventive actions.

• Verify data accuracy through source document reviews, source data verification, and CRF assessments.

• Evaluate investigational products through inventory checks and record reviews.

• Generate timely monitoring reports and correspondence; escalate deficiencies and ensure their resolution.

• Keep in touch with investigational sites between monitoring visits.

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

• Update clinical trial systems and conduct necessary quality-control checks.

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

• Initiate clinical trial sites and ensure adherence to protocols, regulatory requirements, and ICH-GCP standards.

• Manage trial closeout procedures and retrieval of trial materials.

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

• Assist with project publications, tools, trip report evaluations, newsletters, and CRA team meetings.

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

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

• Complete expense reports and timesheets.

• Contribute to project tasks and process improvement initiatives.

⛳️ Requirements

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

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

• A minimum of 1.5 years of experience as the lead Clinical Research Associate (CRA) on Oncology clinical trials.

• Proficient clinical monitoring skills.

• Knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with and application of ICH GCPs, applicable regulations, and procedural documents.

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

• Capability to manage Risk-Based Monitoring concepts and processes.

• Excellent oral and written communication skills when interacting with medical personnel.

• Customer-centric approach, strong listening skills, attention to detail, and the ability to identify underlying issues.

• Interpersonal, organizational, and time management skills.

• Flexibility and adaptability in various situations.

• Ability to work independently or collaboratively within a team.

• Proficiency in Microsoft Office and a willingness to learn relevant software.

• Strong English language and grammar proficiency.

• Competent presentation skills.

• Willingness to comply with sponsor/client/site requirements, including potential vaccination status or other personal information disclosures.

• Ability to travel frequently, typically 60–80%, which may include regular driving and possible extended overnight stays.

• Capacity to work in office, laboratory, clinical, and/or home-office settings while utilizing required personal protective equipment.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.