Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
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 MedicalHlx Life Sciences
Boston, 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 Bost
Job Source: Hlx Life SciencesAllen 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
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 Brisbane and Perth, Australia. Help us build a team that will shape the future of TAVR.
The Clinical Research Associate will manage the daily aspects of investigational site activities on a global pivotal trial. The CRA will ensure compliance with international guidelines, local regulations and corporate policies and procedures, oversee CRO and other vendors to provide site management, and ensure activation, data collection, and data cleaning are completed per the study timeline. This position may also complete site monitoring to comply with regulations and ensure clinical activities comply with organizational SOPs (Standard Operating Procedures) and regulatory requirements.
We will consider candidates at the Senior or Principal level, depending on experience.
Key Responsibilities:
Oversee vendor activities and /or directly participate in study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing and communicating the status of study progress and activities.
Lead the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases.
Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations
Conduct site initiation and monitoring visits; train site personnel, vendors on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site and vendors have the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
Skills, Knowledge, Experience, and Qualifications: Bachelor's Degree in related field with 5+ years of previous field monitoring experience required.
Class III medical device experience preferred; experience with Class III cardiovascular devices strongly preferred.
Experience with site- and sponsor-level FDA BIMO investigation(s)
Excellent written and verbal communication, presentation, interpersonal, and analytical skills required.
Experience working with CROs, core labs and other external vendors
Demonstrated problem-solving and critical thinking skills. High attention to detail.
Proven expertise in MS Office suite, including Word, Excel, PowerPoint, and Adobe
Experience working in a medical device or regulated industry preferred.
Experience with electronic data capture.
Thorough knowledge of Good Clinical Practice (GCP) is required as well as working knowledge of FDA, ISO and other applicable regulations
Clinical research certification (ACRP or SOCRA, Clinical Coordinator / CRA certification) preferred.
Ability to travel up to 50% required (across US and Canada)
Preference given to qualified candidates in the Boston or Minneapolis metro areas; next level preference to candidates in the Central or Eastern time zone.
What We Offer: Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
Collaborative and dynamic work environment with a culture of innovation and excellence.
Competitive compensation package, including salary, performance-based bonuses, and stock options.
Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings: Medical, Dental, and Vision Offerings
Flexible Spending Account (FSA)
401k + Company Match
Life, AD&D, Short Term and Long-Term Disability Insurance
Bonus Plan Eligibility
Employee Stock Option Plan
Paid Holidays & Vacation
Employee Assistance Program
Inclusive Team Environment
#J-18808-Ljbffr
Email Alert for Clinical Research Associate jobs in Boston, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.