(Sr) Clinical Research Associate (Midwest/Northeast)

Location
Burlingame, California, United States
Posted
Oct 25, 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/Northeast) 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; Candidate must be located in the Midwest/Northeast region
  • Compensation: Competitive and commensurate with experience; including strong equity package
  • Benefits: Medical, dental, and vision; 401(k) and more


Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.