Senior Field Clinical Research Associate - MedTech Trials

NAMSA

United States

À distance

USD 69 000 - 134 000

Plein temps

Il y a 6 jours
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Résumé du poste

NAMSA in the United States is seeking an experienced Clinical Research Associate to monitor studies, ensure human subject protection, GCP adherence, and regulatory compliance across sites.

You will coordinate site qualification, initiation, interim visits, and close‑out, serve as the main contact for sites, and contribute to study documentation and reporting. English fluency, a higher education degree, and 3–5 years of trial experience are preferred, with travel up to 20%–80%.

Qualifications

  • Fluency in English and local language, if different, required.
  • Higher education degree or equivalent education, training, and experience.
  • Preferred 5 years clinical trial experience.
  • Preferred 3 years monitoring experience.
  • Preferred 1 year device trial experience.

Responsabilités

  • 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.

Connaissances

English fluency
Independent worker
Communication skills
Organizational skills
Computer literacy

Formation

Bachelor's degree or equivalent

Description du poste

NAMSA in the United States is seeking an experienced Clinical Research Associate to monitor studies, ensure human subject protection, GCP adherence, and regulatory compliance across sites.

You will coordinate site qualification, initiation, interim visits, and close‑out, serve as the main contact for sites, and contribute to study documentation and reporting. English fluency, a higher education degree, and 3–5 years of trial experience are preferred, with travel up to 20%–80%.

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