Apply on Employer Site

NAMSA · 1 day ago

Clinical Research Associate - NAMSA Future Openings USA

Minneapolis, MN

Full-time

Hybrid

Entry Level

$54K/yr - $80K/yr

2+ years exp

NAMSA is a pioneering company in the medical device testing industry, focusing on safety and regulatory compliance. The Clinical Research Associate will manage clinical site monitoring and ensure adherence to Good Clinical Practice and regulatory guidelines while serving as the primary contact for study-related inquiries.

Medical Device

Responsibilities

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

May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits

Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed

Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns

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 files. Tracks and maintains required study documents, performs quality control review, manages renewals

Tracks study site and overall 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

OUS: Prepares and coordinates submissions to regulatory authorities

May perform other activities as assigned

Qualification

Clinical trial experienceMonitoring experienceRegulationsBasic computer proficiencyCommunication skillsOrganizational skillsHigher education degreeSoCRAACRP CertificationFluency in English

Required

Fluency in English and local language, if different, required

Higher education degree or equivalent education, training, and experience

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

Preferred

2 years clinical trial experience

monitoring experience

Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required