Overview This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $70.00/hr - $80.00/hr 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. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.s CCPA Privacy Policy at Seniority level Mid-Senior level Employment type Contract Job function Research and Science Referrals increase your chances of interviewing at Bayside Solutions by 2x Sign in to set job alerts for “Clinical Research Associate” roles. Locations with recent postings: Menlo Park, CA; Foster City, CA; Redwood City, CA; San Mateo County, CA; San Francisco Bay Area. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Bayside Solutions
...Job Description Description A Brief Overview The Pharmacy Intern is an advanced technician-level position and duties are designed... ...profile, pharmacokinetic evaluation Apply federal and state legal standards surrounding medication use Understand the process and...
...We are currently on the lookout for an experienced Non-CDL Bus Driver to join our elite team in Columbus, Ohio for our contract with... ...weather concerns \n \n\n \n About Transdev: Cities, counties, airports, companies, and universities across the U.S. contract with...
...time Scheduling: Flexible; we will accommodate YOU (our programs are 24/7, so we're looking for days, nights, and weekends each month) Where our physicians work: 100% Remote from their home base or office Our Support: Licensing, Credentialing, 24/7 Tech Support...
...actively interviewing for an Outpatient Psychologist to join our clinical faculty in providing exceptional patient care. Join our full-... ...opportunities for teaching and supervision in our American Psychological Association-accredited doctoral clinical psychology...
...Rescue is looking to add a part-time employee to handle social media, volunteer coordination, and grant writing for our 501(c)(3) non-profit organization located in Laurel Canyon. At Ace of Hearts, we are dedicated to stepping in to rescue dogs of all ages, sizes...