(Sr) Clinical Research Associate (Midwest/South)
- Employer
- Inflammatix, Inc.
- Location
- Burlingame, California, United States
- Start date
- Sep 14, 2020
View more
- Discipline
- Clinical, Clinical Research
- Required Education
- Associate Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
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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:
QUALIFICATIONS:
KNOWLEDGE, SKILLS, AND ABILITIES:
COMPENSATION AND CLASSIFICATION:
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
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