Job Description

Clinical Research Associate

Position Location: Twin Cities, MN (White Bear Lake preferred)

Travel Requirement: Approximately 25%, may fluctuate depending on enrollment

Summary:

A pioneering medical technology company is seeking a Clinical Research Associate (CRA) with sponsor experience to support a pivotal study involving a fully implantable cochlear implant. This role offers long-term career growth and advancement opportunities within the organization, providing a pathway to develop professionally while making a meaningful impact on patient care. This individual will be responsible for the oversight of seven clinical investigation sites and 56 patients, ensuring the smooth conduct and monitoring of clinical trials from start-up to closure. The ideal candidate will be local to the Twin Cities, with a willingness to come into the office periodically and travel as needed. This role requires strong experience in medical device clinical investigations, ideally in ear or implant technology, and a background in training program development. The position reports to the Clinical Research Director.

Why Join Us:

You will be at the forefront of groundbreaking medical technology, working on the world’s first fully implantable cochlear implant. Our team is collaborative, passionate, and driven by a commitment to improve the quality of life for patients. We foster an environment of mentorship and professional development, where team members are encouraged to grow their skills and advance their careers within the organization. Join a passionate and innovative team committed to improving the quality of life for hearing-impaired individuals. We offer a collaborative and dynamic work environment where your contributions make a tangible impact on patient care and clinical outcomes. With opportunities for professional growth and involvement in cutting-edge research, you will be part of a mission-driven company that values dedication, innovation, and teamwork.

Key Responsibilities:

• Collaborate effectively with cross-functional teams and stakeholders to ensure smooth execution of clinical trial activities and alignment with overall project goals.
• Serve as the primary point of contact for clinical investigation sites throughout the trial lifecycle, including initiation, monitoring, and closure.
• Conduct both on-site and remote monitoring visits to ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Complete source data verification (SDV), reviewing case report forms (CRFs) for accuracy and completeness.
• Manage and resolve queries/data clarifications and verify eligibility criteria.
• Ensure proper documentation practices on trial records, including source documents, CRFs, and essential documents in the Investigator Site File (ISF).
• Oversee the collection and reporting of safety events, ensuring complete and accurate documentation in the electronic data capture (EDC) system and trial records.
• Write and submit monitoring reports for review and sign-off by the Clinical Research Manager.
• Inspect the Trial Master File (TMF) and ISF to maintain accurate and up-to-date documentation.
• Train investigation site personnel and support the planning of investigator meetings.
• Provide input on project-specific plans and collaborate with field clinical team members on equipment and investigational device accountability.
• Prepare equipment and investigational products for shipment to investigation sites.
• Lead site start-up activities, including ISF creation and procurement of trial supplies.
• Maintain accurate records of essential study materials and ensure proper filing and standardization across all studies.

Qualifications: Required:

• Prior experience with cochlear implant studies or hearing-related medical devices is strongly preferred
• Bachelor’s degree (scientific field preferred)
• Minimum 5 years of clinical trial experience, including at least 2 years as a CRA
• Medical device clinical investigation experience
• Experience with sponsor-managed, FDA-regulated clinical trials
• Proficiency with trial management systems (e.g., eCTMS, EDC) and MS Office Suite (Word, Excel, Outlook)
• Strong understanding of GCP and FDA medical device regulations
• Excellent written and oral communication skills
• Ability to manage multiple projects with strong time management and organizational skills
• Flexible working style and attention to detail

Preferred:

• Class III medical device experience
• Certification by ACRP, SOCRA, or a similar organization
• Knowledge of EU Medical Device Regulations

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