First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Discipline: Clinical Research Associate (CRA)

Location: United States

Senior Clinical Study Associate - Contract - Cambridge, MA (hybrid role)

Be the backbone of clinical research-join a team shaping tomorrow's therapies.

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is seeking a Senior Clinical Study Associate for a hybrid role based in Cambridge, MA. This is an excellent opportunity to contribute to complex clinical trial activities and collaborate with cross-functional teams.

Primary Responsibilities:

The successful candidate will play a key role in supporting the execution of clinical trials, focusing on site start-up, patient enrollment, monitoring, and data flow metrics.

Skills & Requirements:

Strong understanding of clinical trial processes and regulatory requirements.
Experience with TMF management and document tracking.
Proficiency in managing laboratory vendors and coordinating sample logistics.
Ability to review and analyze site performance metrics and monitoring reports.
Excellent organizational and communication skills.
Familiarity with site contracts, budgets, and feasibility assessments.
Ability to work collaboratively with cross-functional teams and external vendors.

The Senior Clinical Study Associate's responsibilities will be:

Oversee day-to-day clinical trial execution, including site start-up, patient enrollment, and monitoring.
Support the Clinical Study Manager and team members in managing trial activities.
Prepare study documents such as consent forms, site instructions, and study-specific materials (e.g., Manual of Operations, Pharmacy Binder).
Track essential documents, ensuring accuracy and proper filing in the Trial Master File (TMF).
Monitor patient status at investigative sites and ensure accurate tracking.
Manage sample collection, laboratory testing schedules, and central laboratory reporting.
Assist with laboratory vendor management and liaise with CROs and clinical trial sites for sample handling and result reporting.
Review monitoring trip reports, track data query reports, and assess site visit metrics and performance.
Participate in site initiation, routine monitoring, and close-out visits, including co-monitoring with CROs.
Ensure data quality from clinical sites and assist in resolving subject eligibility and protocol deviation issues.
Contribute to investigator and vendor meetings, including preparation and presentations.
Support study feasibility assessments and review site contracts and budgets for start-up.
Coordinate third-party vendor activities, including metrics, accruals, and process planning.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /privacy-policy