FSP Clinical Research Associate II
New
L
LifelancerClinical Research
This posting is available to candidates located in the Western United States (WA, OR, CA, MT, ID, WY, UT, CO, AZ, NV, NM).Full-TimeMiddle
SalaryUSD 88600 - 132000 / year
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Job Details
- Languages
- English
- Experience
- 2+ years as a clinical research monitor
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree in a life sciences field, Registered Nursing certification, or equivalent qualification.
- 2+ years of experience as a clinical research monitor or equivalent.
- Strong understanding of ICH-GCP guidelines, medical terminology, and applicable regulations.
- Proficiency in risk-based monitoring concepts and root cause analysis.
- Effective oral and written communication and interpersonal skills.
- Ability to travel domestically up to 75%.
- Valid driver's license.
- Proficiency in Microsoft Office suite.
- Excellent organizational, time management, and critical thinking skills.
Responsibilities
- Monitor investigator sites using a risk-based approach, identifying and resolving site process failures.
- Ensure data accuracy through source data verification (SDV) and case report form (CRF) review.
- Conduct site visits to assess protocol, regulatory, and ICH-GCP compliance.
- Manage study systems and provide trial status tracking updates to the Clinical Team Manager.
- Coordinate investigator meetings and assist in identifying qualified investigative sites.
- Ensure completeness of essential study documents according to regulatory requirements.
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