Planet Pharma
Sr Staff Clinical Research Associate
Planet Pharma, San Diego, California, United States, 92189
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Sr Staff Clinical Research Associate
role at
Planet Pharma . Target Pay Rate: $66.75 - $83.50/hr. Salary will be commensurate with experience. Job Description
Provides clinical support for diagnostic product development to achieve clearances and approvals in the US and internationally. Manages clinical trial sites and ensures successful conduct of clinical studies in compliance with applicable regulations and guidelines. Reviews, assesses, and interprets data from studies. Conducts clinical compliance activities and may oversee multiple studies. Key Responsibilities
Manage daily operations of clinical trial sites across multiple projects. Build relationships with external clinical sites. Manage multiple trials including investigator selection, enrollment analysis, documentation preparation, and investigator meetings. Coordinate with business development for external site contracts. Submit protocols and documents to IRBs/ECs and follow up for approval. Monitor trials in accordance with SOPs, GCP, FDA, and international regulations. Assist in preparing study-specific binders, logs, and forms. Manage clinical trial materials, including ordering, shipping, and inventory control. Develop enrollment strategies to meet study goals. Coordinate shipment of samples and data collection when using central labs. Track CRFs and ensure timely data entry and query resolution. Evaluate clinical data and prepare reports. Participate in meetings to review ongoing trial progress. Review UADEs, obtain approvals, notify sites, and ensure compliance. Maintain comprehensive project files, including ethics approvals, investigator CVs, protocols, and correspondence. Participate in audits and inspections. Contribute to departmental planning and SOP development. Mentor junior CRAs to enhance team skills. Note: Responsibilities may evolve based on business needs. Minimum Qualifications
Bachelor's Degree Master's Degree (preferred) PhD (preferred) Planet Pharma is an equal opportunity employer committed to diversity and inclusion. Additional Details
Seniority level: Not Applicable Employment type: Full-time Job function: Research, Analysis, IT Industry: Staffing and Recruiting Referrals can double your chances of interview success. Notifications available for similar jobs in San Diego, CA, and other locations.
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Sr Staff Clinical Research Associate
role at
Planet Pharma . Target Pay Rate: $66.75 - $83.50/hr. Salary will be commensurate with experience. Job Description
Provides clinical support for diagnostic product development to achieve clearances and approvals in the US and internationally. Manages clinical trial sites and ensures successful conduct of clinical studies in compliance with applicable regulations and guidelines. Reviews, assesses, and interprets data from studies. Conducts clinical compliance activities and may oversee multiple studies. Key Responsibilities
Manage daily operations of clinical trial sites across multiple projects. Build relationships with external clinical sites. Manage multiple trials including investigator selection, enrollment analysis, documentation preparation, and investigator meetings. Coordinate with business development for external site contracts. Submit protocols and documents to IRBs/ECs and follow up for approval. Monitor trials in accordance with SOPs, GCP, FDA, and international regulations. Assist in preparing study-specific binders, logs, and forms. Manage clinical trial materials, including ordering, shipping, and inventory control. Develop enrollment strategies to meet study goals. Coordinate shipment of samples and data collection when using central labs. Track CRFs and ensure timely data entry and query resolution. Evaluate clinical data and prepare reports. Participate in meetings to review ongoing trial progress. Review UADEs, obtain approvals, notify sites, and ensure compliance. Maintain comprehensive project files, including ethics approvals, investigator CVs, protocols, and correspondence. Participate in audits and inspections. Contribute to departmental planning and SOP development. Mentor junior CRAs to enhance team skills. Note: Responsibilities may evolve based on business needs. Minimum Qualifications
Bachelor's Degree Master's Degree (preferred) PhD (preferred) Planet Pharma is an equal opportunity employer committed to diversity and inclusion. Additional Details
Seniority level: Not Applicable Employment type: Full-time Job function: Research, Analysis, IT Industry: Staffing and Recruiting Referrals can double your chances of interview success. Notifications available for similar jobs in San Diego, CA, and other locations.
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