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.
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).
- 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
- Exceptional attention to detail, great follow-up skills, and excellent project management
- 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.