Senior Clinical Research Associate - FS

What You’ll Be Doing:

Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records. Issues, investigates, and resolves any data discrepancies identified during source verification activities. Maintains thorough documentation and proper escalation of issues related to visit reports. Ensures any identified non-compliance issues are addressed.

Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations. Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database. Performs budget negotiations with clinical trial sites.

Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience. 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, must have proven experience in all primary job functions. Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities.

Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO
14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials. Willingness to travel up to 70-85% Experience with Schedule 1 required.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need.

We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.

Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and Med Tech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.