Clinical Operations Specialist
hace 1 mes
We are a biopharmaceutical solutions organization dedicated to accelerating customer success. Our Clinical Development model puts the customer and patient at the center of everything we do, simplifying and streamlining our work to make us easier to work with and for.
Job Description:This role is part of our team responsible for site management activities, ensuring compliance with protocol requirements, study procedures, and relevant guidelines. You will assist Clinical Monitoring staff with daily tasks and serve as a Sponsor representative for sites on assigned studies.
Key Responsibilities:
- Perform activities in compliance with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions
- Assist with site management activities, including serving as a Sponsor representative for sites on assigned studies
- Create and maintain project files, handle project correspondence
- Participate in file audits
- Maintain, update, and input clinical tracking information into databases
- Track incoming and outgoing clinical and regulatory documents and updates
- Manage shared mailbox, process site requests, and route correspondence appropriately
- Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials
- Assist with coordination of team meetings, attend meetings, and prepare accurate meeting minutes and action items
- Routinely anticipate, identify, and resolve potential issues and implement corrective actions
- Maintain overall awareness in the field of clinical research and assigned areas by completing all necessary training
- May provide training or mentorship to more junior level Clinical Operations Specialists
To be successful in this role, you will need:
- An Associate's degree or equivalent experience in clinical research/pharma/biotech or related field
- Good knowledge of medical terminology, clinical data, and ICH/GCP
- Ability to successfully prioritize and work on multiple tasks
- Strong attention to detail, accuracy, and organizational skills
- Excellent communication, presentation, and interpersonal skills
- Ability to embrace new technologies
We offer a competitive salary range of $65,000 - $85,000 per year, depending on experience, plus benefits and opportunities for growth and development.
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