Clinical Research Associate

CenExel

12d•Hybrid

About The Position

The Clinical Research Associate plays a vital role in the development of new medical treatments by monitoring clinical trials and ensuring they are conducted ethically, accurately, and in compliance with regulatory standards.

Requirements

Must be able to effectively communicate verbally and in writing.
Bachelor’s degree in life sciences, health sciences, nursing, or a related field.
1–3 years of experience in clinical research.
Strong understanding of clinical trial processes, GCP, and regulatory guidelines.
Excellent attention to detail and organizational skills.
Proficiency with clinical trial management systems (CTMS) and Microsoft Office Suite.
Strong communication and interpersonal skills.

Nice To Haves

Certification from recognized organizations (e.g., SOCRA, ACRP) is a plus.

Responsibilities

Monitors clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
Conducts site selection, initiation, monitoring, and close-out visits.
Reviews case report forms (CRFs) for accuracy and completeness.
Verifies source documents to ensure data integrity.
Liaises between sponsors and clinical trial sites to resolve issues.
Ensures timely reporting and resolution of adverse events.
Maintains and updates study documentation and records.
Trains site staff on study protocols and compliance procedures.
Ensures proper handling and storage of investigational products.
Prepares monitoring visit reports and presents findings.
Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.