Clinical Research Associate in Baltimore, MD at Apex Life Sciences

Date Posted: 5/25/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Baltimore, MD
  • Job Type:
    Research
  • Experience:
    Not Specified
  • Date Posted:
    5/25/2018
  • Job ID:
    852886

Job Description


POSITION SUMMARY:

Our client seeks a motivated, professional, Clinical Research Associate to perform monitoring activities for design validation studies for registration/premarket approval (CE-IVD and US-IVD) of next-generation sequencing (NGS) IVD assays.

RESPONSIBILITIES:

  • Independently conducts in-house and/or on-site monitoring in accordance with SOPs, ICH/GCP guidelines (SIV, IMV and COV)
  • Participating in assessing study risks
  • Communicates on behalf of the Study Manager with investigators and site staff
  • Prepares study performance reports and study metrics
  • Assists in preparation and independent execution of:
    • Study training presentations for investigators and site staff
    • Study supply ordering and shipping
    • Investigational product release, labeling, accountability at study sites
    • Assist with assay training and proficiency testing activities
    • TMF maintenance
    • Compilation of documents required for inclusion in Clinical Study Report
    • Facilitate document archive activities
    • Assist in Data Management activities (User Acceptance Testing, data entry and data verification as needed)
  • Provides input to cross functional teams regarding study conduct and activities
  • Supports and participates in Clinical Affairs departmental activities
  • Demonstrates self-learning initiative and motivation

May be required to travel intermittently up to 30%.

PREFERRED EDUCATION AND EXPERIENCE:

  • Bachelor of Science or equivalent combination of education and experience
  • 2+ years of previous pharmaceutical or medical device clinical study coordination or clinical study monitoring experience or equivalent
  • Knowledge of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), and Good Documentation Practice (GDP)
  • Experience with IRB/EC submissions
  • Proficient in Microsoft Word, Excel and PowerPoint
  • Excellent written and verbal communication skills
  • Excellent presentation skills
  • Excellent time management and organization skills
  • Ability to work independently
  • A background in molecular biology/biochemistry with laboratory experience preferred

To apply to this position please send resume or contact:

Vickie Dagit. Recruiter

vdagit@apexlifesciences.com

919-334-0178

#LI-VD1