Christopher Caira Email & Phone Number

Billerica -Decentralized

United States

Tarrytown, Ny

Whippany, Nj

Senior Clinical Research Associate- Responsible for all aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites within the approved Clinical Development Plan (CDP) and Monitoring Plan (MP). These global, complex studies are conducted within the standards set by Bayer Global Development, according to Good Clinical Practices (ICH - GCP) and applicable regulatory and legal requirements.- Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.- Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out. o Conducting Site Selection Visits to confirm the Investigator and Site Staff are qualified, and have suitable resources and facilities to properly conduct the study.o Ensuring completion of site documents necessary for ethics and regulatory approval for site initiation within agreed upon timelines. Ensuring all legal, regulatory and Bayer requirements are met prior to drug shipment to sites as well as all site initiation processes are completed.o Ensuring Investigator Agreements and budgets are negotiated and executed for assigned study sites, and subsequently initiating payments at key milestones.o Training and supervising cross functional site personnel on study related procedures for the duration of the study.o Continuously assessing site performance, processes, qualifications of staff, and suitability of facilities to ensure adherence to study protocol, Bayer Healthcare requirements, regulatory and local legal requirements, as well as ICH-GCP.

Raleigh-Durham, North Carolina Area

Worked on the BRIGHT partnership program at Bayer between PRA & Bayer - transitioned to permanent Bayer employee after 11 months.Clinical Research Associate 3- Assigned to complex studies and sites and implemented and monitored clinical trials that ensured sponsor and investigator obligations were met and compliant with applicable local regulatory requirements and ICH-GCP guidelines.- Assessed the qualification of potential investigative sites, initiated clinical trials at investigative sites, instructed site personnel on the proper conduct of clinical trials, and closed clinical trials at investigative sites. - Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely. - Provided regular site status information to team members, trial management, and updated trial management tools. - Completed monitoring activity documents (e.g., PMVR, PTC) as required by PRA SOPs or other contractual obligations. - Worked closely with other clinical team members that facilitated timely resolution of trial and/or clinical issues. - Escalated site and trial related issues per PRA SOPs, until identified issues were resolved or closed.- Performed essential document site file reconciliation. - Performed source document verification and query resolution. - Assessed IP accountability, dispensation, and compliance at the investigative sites. - Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines. - Communicated with investigative sites. - Updated applicable tracking systems. - Ensured all required training was completed and documented. - Functioned independently with minimal oversight required.- Provided leadership skills to assigned projects and within the Clinical Operations department.

Madison, Wisconsin Area

Northeast New Jersey

United States

worked at Covance

Diploma, Nursing

Ba, Communications

Activities and Societies: Theater