Clinical Research Associate Second Sight Medical Products
Second Sight is searching for a Clinical Research Associate. The position participates in
the design, administration and on-site monitoring of company sponsored clinical
trials. This position ensures compliance with clinical protocols, overall clinical objectives,
and national/international regulations and standards for clinical trials. Responsible for
evaluating clinical data.
Essential Duties & Responsibilities:
? Liaise with site personnel regarding the conduct of Second Sight clinical trials.
? Participate in site qualification, site initiation, and site close-out visits.
? Set up clinical trial sites
? Perform interim site monitoring visits which involve travelling to trial sites on a
? Audit and verify data.
? Manage queries and the data clarification process (DCFs) as guided by Data
? Ensure that all adverse events are reported in accordance with the required time
? Review study documentation to ensure protection of subjects? rights, safety and
? Verify that all study logs and forms are being properly maintained at the site.
? Collect completed CRFs from trial sites.
? Write visit reports and follow-up on open action items to ensure appropriate
? File trial documentation, correspondence and reports.
? Ensure accountability of all investigational devices at the site.
? Review site regulatory documents for accuracy and completeness.
? Assist sites in preparation and review of IRB/Ethics submissions.
? Participate in the design of case report forms, informed consent forms and clinical
? Participate in the writing and reviewing of departmental operating procedures and
o BS degree required, preferably in Engineering, Physical or Biological
? Experience Required:
o 1-3 years of experience in monitoring clinical trial sites or a related field.
o Experience in medical devices and/or ophthalmology preferred.
? Required Knowledge:
o Basic understanding of clinical trial regulatory requirements for the
country(ies) to which the position is assigned.
o Basic understanding of ICH Good Clinical Practices and international
standards for clinical investigation of medical devices for human subjects
o Excellent people skills, team oriented
o Effective written and verbal communication skills
o Detail-oriented with strong organizational skills
o Effective problem-solving skills.
o Strong computer skills (word processing and database programs)
o Ability to work under time and resource pressures
||12744 San Fernando Road |
Sylmar, CA 91342