Our client, an emerging biotech scaling its clinical operations function, is seeking a Clinical Research Associate/Coordinator to support the execution of ongoing clinical trials. This is a great opportunity for someone who wants hands-on exposure to a growing pipeline and the chance to help shape processes as the company scales.
Key Responsibilities
Conduct site selection, initiation, monitoring, and close-out visits in accordance with the approved scope of work and Good Clinical Practice (GCP)
Perform on-site and remote monitoring of investigational sites, including source document verification and case report form review
Track site performance, enrollment metrics, and protocol deviations; escalate issues as needed
Maintain and reconcile the Trial Master File (TMF) to ensure inspection readiness
Coordinate with investigators, site coordinators, and internal study teams to keep trial timelines on track
Support regulatory document collection and IRB/EC submissions as needed
Assist with vendor coordination (labs, IRT, imaging, etc.) as applicable to study needs
Qualifications
Bachelor's degree in life sciences, nursing, public health, or a related field (or equivalent relevant experience)
2+ years of CRA or clinical research coordination experience in a pharma, biotech, or CRO setting
Working knowledge of ICH-GCP and FDA regulatory requirements
Experience with EDC systems, CTMS, and eTMF platforms
Strong organizational skills and comfort managing multiple priorities in a fast-moving environment
Willingness to travel to site visits as required
Pandologic. Keywords: Clinical Research Associate (CRA), Location: Cambridge, MA - 02238
Numbers & Facts
Location
Cambridge, MA
Industry
Staffing/Employment Agencies
Company Size
10 to 19 employees
Year Founded
2017
Website
http://www.whitecapsearch.com
About Company
At WhiteCap Search we are breaking away from the traditional approach of agency recruiting to enhance the experience of the job search process. From companies looking to hire top talent, to job seekers looking for the best next step in their careers, WhiteCap Search is focused on finding the optimal fit for all parties involved.
Founded by a diverse team of recruiting experts, we have developed a strong foundational knowledge of each industry for which we recruit. We believe in combining best in class technology with rigid ethical standards to create a positive and tailored approach for each employer and job seeker.
The WhiteCap Search team is uniquely positioned to handle both permanent and temporary searches for a wide variety of job functions across all industries. We optimize our extensive network and cutting-edge technology to deliver results successfully and seamlessly. Utilizing our strong foundational knowledge of each industry for which we recruit, we engage our clients as partners by creating a customized plan for every search. We source job seekers proactively so that employers have unparalleled access to both active and passive job seekers. Our rigorous and consistent screening processes enable us to present top, qualified talent to our clients quickly, making the recruitment process as efficient as possible. Our temporary and consulting services provide employers and job seekers with flexibility. Whether it’s providing support during particularly busy times of the year, covering for an employee during a leave of absence or assisting with special projects, we can handle any of our clients’ temporary staffing needs. Additionally, our temporary-to-permanent staffing solutions provide both the job seeker and employer with the ability to evaluate whether they are the right fit for each other before making a long-term commitment.