Clinical Research Associate...

Clinical Research Associate - Key Responsibilities : Conduct qualification, initiation, monitoring, and close-out visits at designated research sites.

Ensure that clinical studies are conducted in accordance with protocols, Good Clinical Practices (ICH-GCP), and local regulatory requirements.

Prepare, review, and collect all required regulatory documentation before, during, and after site visits.

Oversee study integrity and safeguard participants rights and well-being.

Manage investigator files, ensuring they are complete, updated, and properly organized.

Verify randomization procedures, blinding, and drug accountability according to protocol.

Ensure proper acquisition of informed consent from participants.

Support audits and inspections, coordinating requirements between sites, auditors, and sponsors.

Act as the point of contact between investigators, sponsors, and project teams.

Support site staff training and contribute to the development of new CRAs.

Participate in meetings, courses, and training sessions for ongoing technical development.

Comply with all regulations, SOPs, and quality and ethical standards.

Assist with investigator payments and participant reimbursements.

Collaborate with the regulatory team on submissions to authorities and ethics committees.

Academic Background : Degree in Health SciencesPostgraduate studies in Health Sciences (desirable)Languages : Advanced EnglishSpanish (desirable)Experience Required : Minimum of 3 years of previous monitoring experience in a CRO.