Job Title: Clinical Research Associate (CRA) – Contract
Location: US (Remote)
Department: Clinical Operations
Reports to: Clinical Project Manager or Clinical Operations Manager
Job Summary:
The Clinical Research Associate (CRA) is responsible for monitoring clinical trials to ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and study protocols. The CRA works closely with investigators, site staff, and sponsors to ensure the quality and integrity of clinical data and the safety of trial participants.
Key Responsibilities:
- Monitor clinical trial sites to ensure adherence to protocols, regulatory requirements (e.g., FDA, EMA), and GCP.
- Conduct site qualification, initiation, monitoring, and close-out visits.
- Review source documents, case report forms (CRFs), and ensure accurate data collection.
- Identify, document, and follow up on protocol deviations, adverse events (AEs), and serious adverse events (SAEs).
- Train and support site staff on study procedures and documentation requirements.
- Assist in preparation of study-related documentation, including monitoring plans and reports.
- Collaborate with cross-functional teams including regulatory affairs, data management, and biostatistics.
- Ensure timely resolution of queries and site issues.
- Maintain trial master file (TMF) and site files in compliance with SOPs and regulations.
- Support audits and inspections by regulatory authorities or sponsors.
Qualifications:
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
- 1–3 years of experience in clinical research or monitoring preferred.
- Knowledge of ICH-GCP guidelines and applicable regulatory requirements.
- Strong organisational, time management, and communication skills.
- Willingness to travel up to 60–80% of the time (depending on role and study).
- Proficient in Microsoft Office and electronic data capture (EDC) systems.
Preferred Skills:
- Experience with Phase I–IV clinical trials.
- Prior work in therapeutic areas such as oncology, cardiology, CNS, or infectious diseases.