Clinical Research Associate Jobs
By Candel Therapeutics At Needham, MA, United States
Knowledge of project management tools and practices, and proficiency in using normal office software; Microsoft Word, Excel and PowerPoint.
Participate in maintaining accuracy within clinical management systems and internal reports and trackers.
Able to manage multiple projects independently and use varying databases and management systems.
Minimum 1-3 years relevant clinical research experience.
Excellent verbal and written communication skills, good organizational and interpersonal skills, and a team drive.
Knowledge of GCP and FDA regulations related to clinical trial conduct and familiarity with industry best practices.
Clinical Research Associate Jobs
By Lyra Therapeutics At Watertown, MA, United States

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) ...

Research Associate, Clinical Biomarker Laboratory, Virus Neutralization Assays & Bio-Analytics
By Moderna At Norwood, MA, United States
Identify and resolve quality issues and report issues to upper management
Good computational skills, preferably experienced with Word, Excel, Power Point, GraphPad Prism
Conduct assay development, qualification/validation and sample analysis on a variety of platforms (ELISA, MSD, Ella, Automated ELISA Workstation etc.)
Assume assigned general laboratory responsibilities, e.g., safety coordinator, instrument/process/technology owner etc.
Bachelor or MSc in bioanalysis or related field with immunoassay experience preferably in a regulated environment
Good written, presentation, and interpersonal communication skills
Sr. Clinical Research Associate (100 % Remote)
By Thrive At Cambridge, MA, United States
Assist with essential documents collection, review and archiving (TMF management)
Provide project management support for PTX project team, including vendor oversight
Conduct Site Initiation, Routine, and Close-out monitoring site visits, either on-site or remotely, prepare visit correspondence and records including trip reports
Oversee the conduct of assigned study sites, including ensuring compliance with SOPs, federal and local regulations, and ICH and GCP guidelines
Assist in the review and /or development of clinical trial documents such as study plans and training materials
Participate in and assist with facilitation of project team meetings
Clinical Research Associate Jobs
By Aequor At Waltham, MA, United States
Experience in operation of multiple flow cytometry platforms (e.g.: Client, Sony, etc.) and specialized analysis software (e.g.: FlowJo, ...)
Previous experience with flow cytometry, hands-on experience in developing flow cytometry-based methods.
Hands-on experience with gene editing technologies is a plus.
Prior experience with the following is preferred
Cell isolation, sample preparation and staining
Must be proficient in cell-based assay development and molecular techniques.
Senior Clinical Research Associate
By Alexion Pharmaceuticals, Inc. At Boston, MA, United States
Training, supporting, and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
Minimum of 4 years of CRA monitoring experience
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
Excellent knowledge of relevant local regulations.
Clinical Research Associate Jobs
By Digital Prospectors At Cambridge, MA, United States
Good conflict management and negotiation skills.
Attend qualification and site initiation visits.
Assist the Clinical Trial Manager in the review of ICFs and essential documents.
Track clinical supply shipments and manage shipment logistics.
Strong communication skills both verbally and written in English.
Minimum of 2-3 years demonstrated site monitoring experience in a biotechnology, pharmaceutical, and/or CRO company.