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Hlx 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 SciencesAnteris 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 LtdMapLight Therapeutics, Inc.
Burlington, MA, United States
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What Y
Job Source: MapLight Therapeutics, Inc.Tufts Medicine
Boston, MA, United States
We’re saving lives, building careers, and reimagining healthcare. We can’t wait to grow alongside you. Job Profile Summary This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and
Job Source: Tufts MedicineAlira 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 HealthPhilips
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: PhilipsTufts Medicine
Boston
We’re saving lives, building careers, and reimagining healthcare. We can’t wait to grow alongside you. **Job Profile** **Summary** This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Progr
Job Source: Tufts MedicineBRIOHEALTH 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 INCBoston, 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 new technological capabilities to improve a patient’s health, comfort, and quality of life.
Objective
We are seeking a motivated and enthusiastic Clinical Research Associate (CRA) to join our team. We are on a mission to revolutionize endovascular procedures, promoting procedure advancements and ensuring equitable care. As a CRA at Microbot Medical, you will play a pivotal role in managing our US trials, contributing to the success and growth of our innovative technologies. This position offers an exciting opportunity to work in a fast-paced startup environment and engage in a variety of tasks, fostering professional development and personal fulfillment.
This position will play a pivotal role in building the Company’s position in the robotic surgery space. The Clinical Research Associate will report directly to the Chief Medical Officer (CMO).
Main Responsibilities
Collaborate in the development and execution of clinical and project management strategies to support US trials.
Engage in all stages of clinical studies, overseeing study startup activities and maintaining involvement throughout the trial and closeout activities.
Facilitate communication with study vendors and assist in coordinating site activities, ensuring smooth study maintenance.
Some activation activities will include: Collect and manage essential regulatory and site personnel documents, coordinating approvals and ensuring compliance.
Support the negotiation of contracts and budgets.
Provide training to sites on protocol, proper data collection, and safety event reporting.
Support the development of site initiation visit (SIV) materials, coordinate SIV activities and training, and manage CMS submissions.
Oversee investigational product controls, inventory tracking, and investigational device shipment and return procedures.
Maintain the eTMF in collaboration with various stakeholders, ensuring data integrity and accuracy.
Collaborate with the Director and CRO to create necessary study materials, including worksheets, CRFs, study logs, reports, and tracking tools.
Proactively drive enrollment initiatives and propose migration strategies to enhance study efficiency.
Assist sites with protocol adherence, and regulatory requirements throughout the lifecycle of the trial.
Qualifications & Requirements:
Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
Minimum of 3+ years of clinical research experience in the medical device industry.
Strong knowledge of FDA regulations, GCP guidelines, ICH guidelines, ISO guidelines, and MDR
reporting.
Exceptional attention to detail, great follow-up skills, and excellent project management
abilities.
Ability to work both independently and collaboratively within a team environment.
Outstanding interpersonal skills, proficient oral and written communication in English.
Strong problem-solving skills, work drive, and focus.
Positive demeanor and keen awareness in a dynamic environment.
Proficiency in remote work, demonstrating effective productivity with minimal supervision.
Familiarity with electronic data capture (EDC) systems and electronic trial master file (eTMF).
Willingness to travel up to 10% of the time.
A strong desire to learn, grow, and develop career skills.
If you meet the above requirements and are excited about this opportunity, please submit your resume for consideration. We offer a competitive salary, comprehensive benefits package, and a dynamic and collaborative work environment. Join us at Microbot Medical to make a significant impact on the future of endovascular care and contribute to meaningful advancements in medical device technology and patient care.
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Email Alert for Clinical Research Associate jobs in Boston, MA, United States
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