Job Description

Join to apply for the Clinical Research Associate role at Planet Pharma . Get AI-powered advice on this job and more exclusive features. Job Description This position involves monitoring and oversight of clinical sites to ensure the timely and successful execution of clinical studies, resolving study-related discrepancies. The role includes ensuring compliance with protocol and all regulatory policies, procedures, and guidelines during clinical studies by training and guiding investigators and study coordinators, and following up on corrective actions. Additionally, the CRA will ensure the validity of the study by identifying and resolving discrepancies, obtaining missing data, and tracking routine aspects of clinical documents, which may include protocols, case report forms (CRFs), memos, correspondence, reports, and other required documents. The CRA may also conduct new CRA orientation, onboarding, and training activities. Responsibilities 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 clinical leadership. Maintain clinical operations processes, including onboarding new employees, internal protocol training, monitoring tracking tools, and study tools/templates for CRAs and site personnel. Manage CROs/vendors for outsourced activities, including sponsor oversight of study management, monitoring, site management, project master files, and data management. Ensure adherence to Good Clinical Practices, industry standards, SOPs, and all other regulatory and quality standards in clinical research. Operate with minimal supervision and demonstrate a high degree of proficiency. Undertake additional projects and tasks as needed. The successful candidate will work collaboratively across cross-functional teams, including Quality, Compliance, Product Development, and Engineering. Prior experience in clinical research or clinical trials and a solid understanding of related processes are required. The role demands a quick thinker, adaptable to evolving workflows, proactive in seeking clarification, resourceful, and capable of independent work. Creativity in problem-solving and openness to innovation are valued. The candidate should learn internal processes quickly and work independently with minimal supervision, taking initiative in a fast-paced environment. Education & Certifications Bachelor's degree in Biology, Health Sciences, Mathematics, Computer Science, or related field. Certifications like CCDM are a plus but not required. Compensation & Other Details Pay ranges between $42-49/hr based on experience. The Planet Group of Companies is an equal opportunity employer committed to diversity and inclusion. Additional Information Employment type: Full-time Job function: Research, Analysis, IT Industry: Staffing and Recruiting #J-18808-Ljbffr Planet Pharma

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