- 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.
- 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.
- 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.
- 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
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Clinical Research Associate - Boston, United States - Anteris Tech
Description
Job Description
Job DescriptionSalary: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:
Skills, Knowledge, Experience, and Qualifications:
What We Offer:
Health and Wellness Offerings:
remote work
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