(Sr) Clinical Research Associate (Midwest/South)

Location
Burlingame, California, United States
Posted
Sep 14, 2020
Ref
4108597003
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
SUMMARY OF ROLE:

We are seeking an experienced (Sr) Clinical Research Associate (Midwest/South) to play a key role in proactively supporting the conduct of clinical studies. The CRA will conduct site monitoring visits as well as perform in-house CRA responsibilities. This role will not be boring! Success will lead to increased exposure to advanced responsibilities and career growth opportunities. On the job learning and a desire to say "yes" to new things are expected. The candidate will report to the Head of Clinical Operations. This role is remote.

PRIMARY RESPONSIBILITIES:
  • Preparation, conduct, and reporting of monitoring visits (pre-study, initiation, routine monitoring and closeout visit) per monitoring plan and applicable SOPs
  • Provide protocol and related study training to assigned sites and serves as the main liaison to participating in clinical trial sites with a focus on data entry, query resolution, clinical sample shipment, recruitment, and overall site activity
  • Ensures the data cleaning process is performed and performs source data verification of study data entered into EDC
  • Collaborates regularly with study lead and clinical study sites to ensure timely delivery of study milestones
  • Contribute to the preparation and amendments of study-related documents (informed consent forms, clinical trial agreements, budgets)
  • Assists with organizing IRB/EC submissions with follow through to ensure successful outcomes
  • Participate in the development of project-specific documents (protocol, ICF), plans (e.g., Clinical Monitoring, Communication, etc.), and other study-related documents
  • May participate in vendor management, data management, or safety activities
  • Maintain trial master file essential documents and clinical trial tracking systems
  • Ability to travel up to 70%

QUALIFICATIONS:
  • BS degree in relevant field
  • ACRP/CCRA or equivalent certification/credentials preferred
  • 2-5 years of (CRA) monitoring experience in the pharma, IVD, or CRO industry

KNOWLEDGE, SKILLS, AND ABILITIES:
  • Experience with EDC systems
  • A thorough understanding of clinical processes, ICH, and associated regulatory guidelines
  • Excellent verbal and written communication
  • Knowledge of infectious disease or emergency or ICF medicine a plus but not required
  • Excited to 'wear many hats' and self-motivated to take on new challenges
  • Well organized and detail-oriented

COMPENSATION AND CLASSIFICATION:
  • Classification: Full-time position
  • Compensation: Competitive and commensurate with experience; including strong equity package
  • Benefits: Medical, dental, and vision; 401(k) and more