Clinical Trial Manager – Cardiovascular Medical Device
MiRus is an innovative healthcare company with a growing portfolio of cardiovascular and orthopedic products and deep proprietary technology in both implants and procedural solutions. MiRus was started by a team of experienced entrepreneurs with a history of creating disruptive technologies and very successful, highly valued companies.
We offer competitive compensation, options, and full benefits.
Job Summary
Assist with the management of cardiovascular clinical studies for MiRus products with a focus on adherence to critical timelines, high-caliber document development and quality data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization.
Responsibilities
♦ Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
♦ Assist with the management of investigational studies from start through study closure.
♦ Engage in new study trial design with cross functional teams, including clinical and pre-clinical research and development groups.
♦ Contribute to the development of CRFs.
♦ Assist with the formulation of instructional materials and training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials, as applicable
♦ Assist Study Manager with safety monitoring including preparing supporting documentation for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable.
♦ Serve as a point of contact between clinical site investigators and the MiRus team.
♦ Work with investigators and site personnel to quickly and effectively resolve discrepancies.
♦ May be responsible for patient accruals and tracking payments to sites for clinical study programs.
♦ Serve as a point of contact between CRO personnel and MiRus.
♦ Oversee/support CRO and field study monitors, with monitoring related items and follow-up on study tasks.
♦ Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
♦ Provide continuous data review of source documents, case report forms, data reports as appropriate.
♦ Assist in review of monitoring reports and tracking of action items.
♦ Review source documentation to confirm subject eligibility for clinical trials.
♦ Track and upload study imaging.
♦ Manage clinical study documentation (trial master file and study related tracking).
♦ Update and design as needed study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager.
♦ Interact with data management, as applicable.
♦ Support applications and technical files as needed.
♦ Assist with preparation for investigators meetings.
Requirements
♦ Bachelor’s or Master’s degree in nursing with clinical experience in the cardiac field (CCU, CVOR, Cath Lab) and experience in a clinical research role. CRA certification desired.
♦ At least 2 years of experience in clinical research role, preferably in cardiovascular medical device.
♦ Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
♦ Current knowledge of medical device clinical trials design and best practices.
♦ Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
♦ General application of medical terminology (cardiovascular specific preferred).
Benefits:
MiRus offers competitive compensation, options, full benefits, and relocation assistance.
♦ 401(k)
♦ Dental insurance
♦ Vision insurance
♦ Disability insurance
♦ Employee assistance program
♦ Flexible spending account or Health Savings Account
♦ Health insurance
♦ Life insurance
♦ Paid time off
Schedule:
♦ Monday to Friday (8am – 5pm)
Work Location:
♦ Marietta, GA
♦ Position may require domestic travel up to 10%, however this is an in-house position.