Job details
Job type full-time
Full job description
Namsa pioneered the industry, namsa was the first independent company in the world to focus solely on medical device materials for safetyNamsa started testing medical devices before the u.sFood and drug administration started regulating such products in 1976.
We are shaping the industryNamsa has been a key contributor to the development of the test methods that govern our industry.
We have become the industry’s premier providerWe provide support for clients during every step of the product dev elopment lifecycle and beyond.
Come and work for an organization whose:
Mission is to make a scientific contribution to every medical device in the world.
Culture is passionately committed to the partnership between one another and our clients to improve a nd save lives through a respectful, trusting, and collaborative environment.
Values have stood the test of time.
Above all else, conduct ourselves with integrity
Job description:
Principal duties and responsibilities
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Works on assigned studies to ensure that human subject protection is maintained, good clinical practice (gcp), and applicable regulations are followed.
Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, sops, and applicable regulatory guidelines.
Conducts investigational site qualification, site initiation, interim, and site close-out monitoring visits.
Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concernsFollow-up with sites until deficiencies are resolved.
Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
Performs study-related training.
Manages the development and maintenance of study documents, processes and systems as assigned.
Ensures quality and completeness of central and site master filesTracks and maintains required study documents, performs quality control review, manages renewals.
Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
Attends internal and external meetings as required.
Provides all job-related progress reports and visit documentation as required.
May support safety activities such as narrative writing, managing the cec/dsmb, etc.
Qualifications and skills
Clinical research associate (all)
Fluency in english and local language, if different, required.
Bachelor’s degree or equivalent experience in a related field.
Preferred 2 years clinical trial experience.
Preferred monitoring experience.
Technical competencies
Able to work independently once trained.
Good verbal and written communication skills.
Strong organizational skills.
Basic computer proficiency.
Understanding of clinical research processes and regulations.
Society of clinical research associates (socra) or association of clinical research professionals (acrp) certification strongly preferred.
Working conditions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hearThe employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and armsThe employee must occasionally lift and/or move up to 25 poundsSpecific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
Extensive use of a computer keyboard.
Position descriptions are not intended, and should not be construed to be an exhaustive list of all responsibilities, skills, and efforts or working conditions associated with a jobNamsa reserves the right to revise duties as needed.
Job type: full-time
Work location: multiple locations
