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Recruitment Consultant - Specializing Clinical Operations Consultants - North & South America My Client is a Spanish based CRO company who are looking for a 20 hours a month contractor starting with a 12 month contract with highly likely of extension.
CRA - 7+ years Colombia Regulatory experience (need experience in submitting Clinical trials to the authorities)2 sites in Colombia.
Travel once maybe twice a year to the sites.
Hematology/oncology experience required.
February start.
Contractor with own insurance is required.
A Clinical Research Associate (CRA) is responsible for overseeing clinical trials to ensure that they are conducted according to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
CRAs play a vital role in the clinical research process, often working with pharmaceutical companies, medical device firms, or contract research organizations (CROs) to bring new drugs and treatments to market.
Key Responsibilities: Select, initiate, and monitor clinical trial sites.
Ensure that clinical trials are conducted in compliance with protocols, GCP, and regulatory requirements.
Conduct pre-study visits, site initiation visits, routine monitoring visits, and close-out visits.
Data Management and Quality Assurance: Verify the accuracy and integrity of clinical trial data by reviewing case report forms (CRFs) and source documents.
Ensure that trial data is recorded and reported accurately and timely.
Monitor site performance and resolve any discrepancies or issues.
Compliance and Regulatory: Ensure trials comply with regulatory requirements (FDA, EMA, etc.)
and ethical guidelines.
Confirm that the trial sites have appropriate documentation, including informed consent forms, ethics committee approvals, and regulatory submissions.
Identify any protocol deviations and report serious adverse events (SAEs).
Communication and Reporting: Act as a liaison between the sponsor and the clinical trial site.
Report on the progress of clinical trials and escalate issues as necessary.
Train site personnel on trial protocols, GCP guidelines, and study procedures.
Documentation and Reporting: Maintain essential trial documentation, including trial master files.
Generate detailed monitoring reports following each site visit.
Assist in preparing final clinical study reports.
Key Skills: Strong knowledge of clinical trial processes, GCP, and regulatory guidelines.
Excellent communication and interpersonal skills.
Attention to detail and strong organizational abilities.
Proficiency in medical terminology and clinical research practices.
Problem-solving and decision-making capabilities.
Ability to travel frequently, as site visits may be required.
Educational and Experience Requirements: Education: A degree in life sciences, nursing, pharmacy, or a related field is often required.
Advanced degrees may be preferred.
Experience: 8 years+ of clinical research experience.
Certifications (optional but preferred): Certified Clinical Research Associate (CCRA) by ACRP.
Clinical Research Coordinator (CRC) certification.
Seniority level Mid-Senior level Employment type Contract Job function Research and Project Management Industries Research Services, Biotechnology Research, and Pharmaceutical Manufacturing #J-18808-Ljbffr