Job Description
Clinical Research Associate
W2 Contract
Salary Range: $145,600 - $166,400 per year
Location: Redwood City, CA - Hybrid Role
Job Summary:
The Clinical Research Associate (CRA) will provide appropriate support to the study team and conduct clinical research activities according to SOPs and applicable regulations and guidelines. The CRA is an integral part of the Study Management Team (SMT) and provides operational expertise in document management, patient and site logistics, data review, and vendor management to ensure deliverables to the SMT or other key stakeholders. The CRA will work in a fast-paced environment and proactively communicate with the internal cross-functional team, external clinical site personnel, and vendors to ensure clinical data quality and compliance in the conduct of clinical trials.
Duties and Responsibilities:
- Ensure ongoing management, quality control, and completeness of clinical study documentation (including essential documents from internal teams, vendors, and clinical sites) in compliance with ICH-GCP, company SOPs, and regulatory requirements.
- Conduct periodic Trial Master File (TMF) reviews to identify documentation gaps or inconsistencies and follow up on resolution.
- Support planning, organizing, and tracking of clinical trial activities, including data collection, central Images, electronic patient-reported outcomes (ePROs), study samples, and other clinical trial deliverables.
- Support activities and documentation within various phases of clinical studies (i.e., study planning, site qualification and investigator selection, monitoring, closeout, etc.)
- Draft, review, and/or record Agenda and Minutes for internal and external study-related meetings
- May support the study team through the development and/or review of clinical study plans, presentations, study documents (e.g., review of informed consent forms (ICFs), site-facing documents, and tracking tools), review and tracking monitoring reports, and other activities/duties as assigned
- Communicate and escalate issues to the SMT as required.
- Support company and department initiatives in GCP compliance as it relates to document management or other key areas
- Identify areas of best practice and process improvements.
Requirements and Qualifications:
- Bachelor's Degree in life sciences, pharmacy, healthcare, nursing, or equivalent, combined with education and experience
- Familiarity with DIA TMF structure and essential document management is preferred
- Strong knowledge of GCP, ICH guidelines, and clinical trial regulations
- 2+ years' experience in Clinical Operations with a Sponsor company is preferred
Desired Skills and Experience
Clinical Research Associate, CRA, clinical research, SOPs, regulations, guidelines, Study Management Team, SMT, operational expertise, document management, patient logistics, site logistics, data review, vendor management, cross-functional team communication, clinical site personnel, clinical data quality, compliance, clinical trials, Trial Master File, TMF, ICH-GCP, company SOPs, regulatory requirements, TMF reviews, documentation gaps, clinical trial activities, data collection, central images, ePROs, electronic patient-reported outcomes, study samples, study planning, site qualification, investigator selection, monitoring, closeout, clinical study plans, presentations, study documents, informed consent forms, ICFs, site-facing documents, tracking tools, monitoring reports, GCP compliance, process improvements, life sciences, pharmacy, healthcare, nursing, DIA TMF structure, essential document management, ICH guidelines, clinical trial regulations, Clinical Operations, Sponsor company
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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