- 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 investigator's 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
-
Research Associate/Senior Research Associate
1 week ago
Shape Therapeutics, Inc. Seattle, United StatesShape TX · is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, Shape TX is developing breakthroughs in RNA editi ...
-
Research Associate
2 weeks ago
Monod Bio Seattle, United StatesJob Description · Job DescriptionSalary: 75K - 90K · Monod Bio is a pioneer company in de novo protein biosensors and reporters. Our innovative platform uses the most recent advances in computational protein design and engineering to create highly modular biosensing nano-switches ...
-
Research Associate/Senior Research Associate
1 week ago
Shape Therapeutics, Inc. Seattle, United StatesShapeTX is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, ShapeTX is developing breakthroughs in RNA editing, n ...
-
Research Associate/Senior Research Associate
1 week ago
Shape Therapeutics, Inc. Seattle, United StatesShape TX · is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, Shape TX is developing breakthroughs in RNA editi ...
-
Research Associate
1 week ago
MPOWIR Mentoring Physical Oceanography Women to Increase Retention Seattle, United StatesResearch Associate University of Washington · Application Instructions · Applicants are asked to submit electronically to Sarah Webster ( · and Andr Punt ( · ) the following: 1. a curriculum vitae; 2. a publication list; 3. a cover letter including a personal statement of p ...
-
Research Associate
1 week ago
MPOWIR Mentoring Physical Oceanography Women to Increase Retention Seattle, United StatesResearch Associate – University of Washington · Application Instructions · Applicants are asked to submit electronically to Sarah Webster ( · and André Punt ( · ) the following: 1. a curriculum vitae; 2. a publication list; 3. a cover letter including a personal statement of ...
-
Research Associate
5 days ago
ComforceHealth Seattle, United StatesResearch Associate · - Biotech/R&D/Science · Job ID: · Seattle , · Washington · Job Type: · Contract · Added - 03/01/24 · Job Description · Innova Solutions is immediately hiring for · an · Research Associate , · Position type: · Full time Contract · Duration: 12+ m ...
-
Research Associate
4 days ago
ECS Federal Seattle, United StatesECS is seeking a Research Associate to work in our Seattle, WA office. · Job Description: · Background: · In response to the recently released NOAA Fisheries National Environmental Equity and Justice (EEJ) Strategy, the NOAA Fisheries West Coast Region, Northwest Fisheries Scienc ...
-
Research Associate
5 days ago
ComforceHealth Seattle, United StatesResearch Associate · - Biotech/R&D/Science · Job ID: · Seattle , · Washington · Job Type: · Contract · Added - 03/01/24 · Job Description · Innova Solutions is immediately hiring for · an · Research Associate , · Position type: · Full time Contract · Duration: 12+ mon ...
-
Research Associate
5 days ago
Innova Solutions Seattle, United StatesInnova Solutions is immediately hiring for an Research Associate, · Position type: Full time Contract · Duration: 12+ months · Location: Seattle, WA · As an Research Associate, you will: · Summary: · Responsibilities: · Propose and execute high quality laboratory experi ...
-
Research Associate/Senior Research Associate
2 weeks ago
Shape Therapeutics Seattle, United States Full timeShapeTX is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, ShapeTX is developing breakthroughs in RNA editing, n ...
-
Research Associate
1 week ago
ECS Corporate Services Seattle, United StatesECS is seeking a Research Associate to work in our Seattle, WA office. · Job Description: · Background: · In response to the recently released NOAA Fisheries National Environmental Equity and Justice (EEJ) Strategy, the NOAA Fisheries West Coast Region, Northwest Fisheries Scienc ...
-
Research Associate
1 week ago
Hoffmann-La Roche Ltd Seattle, United StatesThe Position · POSITION SUMMARY · Roche Diagnostics acquired Stratos Genomics (SBX Nanopore Sequencing) in 2020 for its unique chemistry that advances DNA sequencing by nanopore, Sequencing by eXpansion (SBX). You will develop, process and purify the molecular building blocks for ...
-
Research Associate III
1 week ago
Actalent Bothell, United States Full timeDescription: · An oncology biotech company is seeking a collaborative and independent Research Associate III (RA III) to participate in development of antibody-based oncology therapeutics. The RA III will report to the Molecular and Cellular Technologies team lead within Antibody ...
-
Senior Research Associate
3 weeks ago
Sunrise Systems, Inc Seattle, WA, United States*Job Title*: *Senior Research Associate * · *Location: Onsite role in Seattle, WA* · *Duration: 12 months (With possible extension)* · *Position Type: Hourly contract Position (W2 only)* · *Top Skills:* · 2+ years of hands-on lab work on biotech industry · Experience in process d ...
-
Research Associate I
1 week ago
Allen Institute Seattle, United StatesResearch Associate I - Tissue Processing · The mission of the Allen Institute is to unlock the complexities of bioscience and advance our knowledge to improve human health. Using an open science, multi-scale, team-oriented approach, the Allen Institute focuses on accelerating fou ...
-
Senior Research Associate
3 weeks ago
Eclaro Seattle, United StatesJOB TITLE: Senior Research Associate · Location: Seattle, WA (100% ONSITE) · Duration: 12 months initial (potential extension/potential right to hire) · Schedule - 9:00am - 5:00pm · Top Skills: · BS in Biology, Immunology, Cancer Biology, or related field · 3 to 5 years of releva ...
-
Research Associate I
1 week ago
Allen Institute Seattle, United StatesResearch Associate I - Imaging · The mission of the Allen Institute is to unlock the complexities of bioscience and advance our knowledge to improve human health. Our Brain Science team is dedicated to accelerating the understanding of how the human brain works in health and dise ...
-
Research Associate II
3 weeks ago
Allen Institute Seattle, United StatesResearch Associate II - Molecular Biology, Genome Engineering (SeaHub) · The mission of the Allen Institute is to unlock the complexities of bioscience and advance our knowledge to improve human health. Using an open science, multi-scale, team-oriented approach, the Allen Institu ...
-
iPSC Research Associate
2 weeks ago
Momentum Staffing Group LLC Seattle, WA, United StatesA quickly growing biotechnology company is looking for Research Associate to support research projects contributing to the development of novel gene and cell therapy products. This position offers a very challenging and rewarding work environment, within a thriving company. · Res ...
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 Company's 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 individual's qualifications, experience, knowledge, skills, and abilities.
Benefits
In-House Clinical Research Associate professionals in Seattle
-
Jobanpreet Ghumman
United States International Medical Graduate MBBS
-
Tryniti Smith
Clinical Research Manager|Dynamic Logistics Master
-
Ynna Kutney
Ynna Kutney Resume
-
Xin Liu
Applied scientist in Computer Vision/Deep Learning
-
Alessandra Bulzomi
Senior Financial Analyst
-
Helisa Wippel
Research Scientist