Job Description

1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. About Job Description Clinical Research Associate- This position will include monitoring and oversight of clinical sites to ensure timely and successful execution of clinical studies, resolving study-related discrepancies. This position will ensure compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions. Also, will ensure validity of study by identifying/resolving discrepancies and obtaining missing data and may track more routine aspects of a study. of clinical documents, which may include protocols, case report forms (CRFs), memos, correspondence, reports, and other required documents. Also, conduct new CRA orientation, onboarding, and training activities. Candidate will proactively identify, and address issues related to study monitoring and clinical site management. Track and communicate monitoring and site management updates and issues; escalate monitoring-related study timeline and quality risks to the Clinical leadership. Maintain clinical operations processes, new employee onboarding, internal protocol training, monitoring tracking tools and study tools/templates for CRAs and site personnel. Manage CROs/vendors for outsourced activities as applicable, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management). Ensure adherence to Good Clinical Practices, Industry standards, standard operating procedures and to all other regulatory and quality standards in conducting Lingo Clinical research and development. Operate under minimal supervision and demonstrate a high degree of proficiency. Undertake additional projects and tasks as determined by department and organizational needs. The successful candidate will demonstrate the ability to work collaboratively across cross-functional teams, including Quality, Compliance, Product Development, and Engineering, etc. They should have prior experience in Clinical Research or Clinical Trials and a solid understanding of related processes. This role requires someone who is a quick thinker, adaptable to evolving workflows, and proactive in seeking clarification when needed. This role requires a resourceful and agile individual who can think critically, adapt to evolving workflows, and proactively seek clarification when needed. The ideal candidate will also demonstrate creativity in problem-solving and be open to exploring innovative ideas and process improvements. The ideal candidate must be able to quickly learn internal processes and demonstrate the ability to work independently with minimal supervision. While support is always available, this role requires someone who can take initiative and adapt quickly in a fast-paced environment. Education Bachelors degree-Major/Field of Study- Biology, Health Sciences, Mathematics, Computer Science, or equivalent Licenses and Certifications None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have but not required. Pay ranges between $42-49/hr based on experience The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma. Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available. Nice-to-have skills Data Management Project Management Alameda, California Work experience Healthcare Languages English Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Technology, Information and Internet Referrals increase your chances of interviewing at TieTalent by 2x Sign in to set job alerts for “Clinical Research Associate” roles. 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