- Assist with writing and editing of all study related documents including study protocol, study amendments, informed consent forms, committee charters, monitoring plans, study reports and other related clinical and regulatory documents.
- Engage in new study trial design with cross functional teams.
- Contribute to the development of clinical report forms and CRF completion guidelines.
- Manage clinical study documentation tracking, whether in-house or at CRO.
- Support and/or track complete sets of documents presented (or submitted on behalf of the clinical sites) to ethics and regulatory processes and subsequent tracking of site activation activities.
- Assist with training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials as applicable.
- Serve as a point of contact between clinical site study coordinators and the Morair team.
- Regularly prepare and report on study status to internal Morair team.
- Provides Clinical Trial Manager support for tasks between CRO personnel and Morair.
- Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
- Review source documentation to confirm subject eligibility for clinical trials.
- Track study imaging.
- Work with investigators and site personnel to quickly and effectively resolve discrepancies.
- Review data in database for completeness, queries, provide continuous data review of source documents, case report forms, data reports as appropriate, and interact with Data Management as required.
- Assist CRO and/or CRAs in the field with monitoring related items in prepping for and follow-up on study tasks.
- Assist in reviewing of monitoring reports and tracking of action items.
- Assist with the management of investigational studies from start through study closure.
- Update study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager
- Assist with safety monitoring including preparing supporting documentation for IMM/CEC and/or DSMB, meetings, agenda, data review, presentations, updating relevant trackers as applicable.
- Assist with preparation for any investigators meeting.
- BA/BS degree, preferably in scientific or healthcare related field. CRA certification desired.
- At least 2 years of experience in clinical research role for CRA I/II, minimum of 4 years for higher level, preferably in medical device.
- Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
- Must have excellent verbal and written communication skills.
- Superior writing, composition, English grammar skills a must.
- Proficient in Microsoft Word, Outlook, Excel and PowerPoint required.
- Domestic and international travel - Position may require travel up to 10%.
- Ability to work successfully with a variety of internal and external sources.
- Current knowledge of medical device clinical trials design and best practices.
- Proficient knowledge of FDA regulations and ICH 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 (pulmonary specific preferred).
- Knowledge of GCP standards.
- Medical and Vision
- 401K
- PTO
- Annual bonus dependent on individual and company performance
In-House Clinical Research Associate - Seattle, United States - Morair Medtech, LLC
Description
Morair Medtech, LLC is a medical device company developing endobronchial treatments for lung disease. We are looking for an experienced Clinical Research Associate to join our start-up medical device team based in Seattle. The ideal candidate is a self-starter who thrives in a dynamic small company environment.
The CRA will assist study leadership with clinical studies to ensure compliance with study protocols and applicable regulations, and timely study completion. This position is full-time, in-house (remote and in-office schedule) at the Companys headquarters in Seattle, WA.
Responsibilities:
Requirements:
Compensation
The salary range in the Seattle, WA area for this position is $85,000 - $125,000 annually depending on skill level and experience. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Actual compensation will be dependent on factors, including but not limited to, the individuals qualifications, experience, knowledge, skills, and abilities.
Benefits