Clinical Research Assoc III

Clinical Research Associate III

The Clinical Research Associate III will play a pivotal role in the management and oversight of clinical trials, ensuring that they are conducted in compliance with regulatory requirements and company standards. This position is responsible for monitoring study sites, collecting and analyzing data, and ensuring the integrity of the research process. The successful candidate will collaborate with cross-functional teams to facilitate the smooth execution of clinical studies, contributing to the advancement of medical knowledge and patient care. Additionally, the Clinical Research Associate III will provide training and mentorship to junior staff, fostering a culture of excellence and continuous improvement. Ultimately, this role is essential in driving the success of clinical research initiatives that can lead to innovative healthcare solutions.

Minimum Qualifications:

• Bachelor's degree in life sciences, nursing, or a related field.
• At least 3 years of experience in clinical research monitoring.
• Must have oncology experience
• Strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
• Trip report review experience
• PSSV, SIV, IMV, COV and TMF reconciliation experience
• Onsite monitoring experience with at least 3 years

Preferred Qualifications:

• Master's degree in a relevant field.
• Experience with electronic data capture (EDC) systems.
• Certification as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC).

Responsibilities:

• Monitor clinical trial sites to ensure compliance with study protocols and regulatory requirements.
• Conduct site visits, perform source document verification, and ensure data integrity.
• Collaborate with investigators and site staff to facilitate the smooth execution of clinical studies.
• Prepare and review study-related documentation, including protocols, informed consent forms, and reports.
• Provide training and support to junior clinical research associates and other team members.

The required skills for this position include strong analytical abilities, which are essential for evaluating clinical data and ensuring compliance with protocols. Excellent communication skills are necessary for effectively collaborating with site staff and presenting findings to stakeholders. Attention to detail is critical in monitoring clinical trials and verifying data accuracy. Preferred skills, such as proficiency in EDC systems, enhance the efficiency of data collection and management processes. Overall, a combination of these skills will enable the Clinical Research Associate III to contribute significantly to the success of clinical research projects.