Senior Clinical Research Associate
Our client, a global biotechnology organization are expanding their clinical operations team and are currently recruiting for two Senior Clinical Research Associates to join their team on a permanent basis. As a Senior Clinical Research Associate, you’ll play an important role in assisting the Clinical Operations with executing and managing clinical trials. This position is responsible for assisting the Clinical Operations department with managing clinical trials, including onsite co-monitoring, as needed, approximately 10% travel would be associated with this role.

Responsibilities:

• Participates in the development, execution, completion, and reporting of clinical trial(s) according to the regulations, on time and within budget
• Assists in drafting study related documents (protocol, informed consents)
• Assists in start-up activities of clinical studies including Investigator Meetings, selection of trial sites and investigators.
• Assist in managing CRO's/ FSPs under the direction of study managers.
• Attend co-monitoring visits as needed
• Reviews monitoring visit reports from CRO/FSP
• Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources
• Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants
• Writes, reviews, and / or provides input to study plans and guidelines
• Manages trial related materials and vendors, e.g. investigational product supplies, ancillary supplies, central laboratories, central IRB, etc. as assigned
• Assists with the electronic trial master file (eTMF) processes including set-up and QC.
• Ensures the quality control of critical documents
• Collaborates with CRO/FSP counterpart on an ongoing basis
• Performs monitoring (PSV, SIV, IMV, COV), as needed, of clinical trial(s) in accordance with company (or other applicable) SOPs, ICH E6 GCP, and other regulations and guidance as relevant

• BS/BA degree in related field, preferably with a scientific background and 4+ years’ experience in clinical development and operations
• Prefer at least 2 years’ experience performing on-site monitoring conducting SIVs, IMVs, COVs and/or co-monitoring experience for IND regulated clinical research studies
• Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations
• Demonstrated effectiveness in resolving site management issues of varying complexity
• Strong analytical skills
• Professional, proactive demeanor
• Strong interpersonal skills
• Excellent written and verbal communication skills
• Proficient in Microsoft Office