Job Description:

About the Job

The holder of this position will ensure all studies are conducted in accordance with the protocol, International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines, ethical review committees and regulatory guidelines, and all other applicable laws so that human subjects are protected and data produced is of integrity. He/she will lead study monitoring and quality assurance and advise the Principal Investigator on study design and conduct and oversee GCP and human subjects’ protection (HSP) training, certification and adherence for all study personnel.

Responsibilities

Develop and implement monitoring plans for clinical studies.
Conduct site qualification, initiation, interim, and close-out visits.
Ensure compliance with study protocols, ICH GCP, and regulatory requirements.
Review source documents and Case Report Forms (CRFs) for accuracy, completeness, and adherence to data quality standards.
Verify adverse events and serious adverse events are reported appropriately and in a timely manner.
Provide ongoing training and support to study site staff.
Manage study drug and supply accountability.
Prepare and submit monitoring reports and follow-up letters.
Identify and resolve site-related issues and discrepancies.
Participate in the development and review of study-related documents (e.g., protocols, consent forms, SOPs).
Maintain strong communication with study sites, investigators, and the study team.
Conduct quality control checks on study data and documentation.
Oversee GCP and human subjects’ protection (HSP) training, certification and adherence for all study personnel.
Any other duties assigned by the supervisor.

Requirements

Bachelor’s degree in a health-related field (e.g., Nursing, Pharmacy, Clinical Medicine, Public Health).
Certification in Good Clinical Practice (GCP).
At least three (3) years of experience as a Clinical Research Associate or similar role in clinical trials.
In-depth knowledge of ICH GCP guidelines and regulatory requirements for clinical research.
Strong understanding of medical terminology and clinical trial processes.
Excellent communication, interpersonal, and organizational skills.
Proficiency in clinical trial management systems and Microsoft Office Suite.
Attention to detail and strong problem-solving abilities.
Ability to work independently and manage multiple priorities.
Willing to travel extensively and on short notice.