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Microbot Medical
Boston, MA, United States
Job Title: Clinical Research Associate Reports To: Chief Medical Officer (CMO) Location: Boston, MA About Microbot Medical Microbot Medical is a dynamic, publicly traded, global, medical robotic device startup company. Microbot Medical develops robotic devices in the interventional endovascular space that provides doctors and surgeons with
Job Source: Microbot MedicalAnteris Technologies Ltd
Boston, MA, United States
Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisb
Job Source: Anteris Technologies LtdAllen Spolden
Boston, MA, United States
Job Description Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SO
Job Source: Allen SpoldenBRIOHEALTH SOLUTIONS INC
Boston, MA, United States
Job Description Job Description BrioHealth Solutions is looking to add to our growing team. We are looking for Clinical Research Associates(CRA) who are looking to help bring our novel LVAS device to the market. The ideal candidate will be well versed in clinical trial management, where you will be helping manage the data collected
Job Source: BRIOHEALTH SOLUTIONS INCPAREXEL
Billerica, MA, United States
Exciting opportunity for a Clinical Research Associate in the Northeast! The Clinical Research Associate is the clinical sites' direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountabl
Job Source: PAREXELBoston Medical Center
Boston, MA, United States
Position: Senior Clinical Research Associate, OB/GYN Location: Boston, MA Schedule: 40 hours per week, Hybrid ABOUT BMC: At Boston Medical Center (BMC), our diverse staff works together for one goal - to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by ou
Job Source: Boston Medical CenterPhilips
Cambridge, MA, United States
Job Title Senior Clinical Research Associate Job Description Your role: Acting as the Senior Clinical Research Associate for designated clinical studies, while providing leadership in the execution and management of clinical studies, to deliver high quality data to support Philips businesses. Ensuring the clinical studies are monitored and conduc
Job Source: PhilipsAlira Health
Boston, MA, United States
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Descriptio
Job Source: Alira HealthBoston, MA, United States
We are partnered with an innovative medical device business specialising in structural heart solutions.
They are looking to hire a permanent CRA on the East Coast to manage daily site activities, for this first in class product.
TAVR / TAVI, CRO management and class III device experience needed! Preference for qualified candidates based in the Boston or Minneapolis metro areas
The Clinical Research Associate (CRA) will oversee the day-to-day operations of investigational site activities in a global pivotal trial.
Key Responsibilities:
Supervise vendor activities or directly participate in study start-up and conduct, including drafting the ICF study-specific template and TMF plan, approving the study-specific essential documents list, and managing and communicating study progress.
Lead the investigation of discrepancies in study documentation by applying clinical protocol knowledge and GCP, and develop processes to prevent reoccurrence throughout the study phases.
Review documentation required for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents comply with Good Documentation Practices, internal SOPs, and US and international regulations.
Conduct site initiation and monitoring visits, train site personnel and vendors on sponsor and regulatory requirements for study conduct, and participate in site meetings while preparing site initiation visit reports and associated documentation.
Assess all data documentation, reports, records, transcripts, and exam results for consistency with case report forms and monitor clinical trial/study safety in accordance with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information), and regulatory requirements.
Verify trial/study data, maintain appropriate regulatory documents both internally and externally, and audit to ensure the site and vendors have the necessary regulatory documentation to conduct the trial/study, ensuring that source documentation is properly recorded.
Skills, Knowledge, Experience, and Qualifications:
Bachelor's degree in a related field with over 5 years of field monitoring experience required.
Experience with Class III cardiovascular devices.
Experience with site- and sponsor-level FDA BIMO investigations.
Experience working with CROs, core labs, and other external vendors.
Proficiency in MS Office suite, including Word, Excel, PowerPoint, and Adobe.
Experience in the medical device or regulated industry preferred.
Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification) preferred.
Ability to travel up to 50% across the US and Canada.
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Email Alert for Clinical Research Associate jobs in Boston, MA, United States
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