HR Generalist
Biofusion · Denver, CO · Yesterday
Human ResourcesFull-time
About the role
The Clinical Operations Specialist will support the operational aspects of clinical trials. Key responsibilities include managing trial logistics, ensuring compliance with protocols, and assisting with data collection. You will work closely with clinical teams to facilitate smooth trial execution.
Responsibilities
- Support clinical operations in various projects
- Assist in the development of operational strategies
- Monitor project timelines and deliverables
- Collaborate with external vendors
- Lead and manage clinical research projects
- Develop study protocols and budgets
- Ensure compliance with ethical standards
- Mentor junior staff and researchers
- Coordinate daily operations of clinical trials
- Assist in patient recruitment and retention
- Maintain study documentation and records
- Facilitate communication between teams
- Oversee data management processes for clinical trials
- Ensure data integrity and accuracy
- Collaborate with cross-functional teams
- Prepare data reports for stakeholders
- Manage clinical trials from initiation to completion
- Ensure compliance with regulatory requirements
- Coordinate with investigators and site staff
- Monitor patient recruitment and data collection
- Manage trial logistics
- Assist with data collection
- Work closely with clinical teams to facilitate smooth trial execution
- Develop research protocols and manage regulatory submissions
- Oversee a team of researchers and coordinate with external partners
- Manage budgets
- Serve as the primary contact for study participants and site staff
- Develop data management plans and oversee data entry processes
- Monitor study sites, conduct site visits, and maintain study documentation
- Collaborate with cross-functional teams to ensure timely project delivery
Requirements
- Bachelor's degree in Health Sciences or related field
- 2+ years of experience in clinical operations
- Strong organizational and multitasking skills
- Ability to work independently and as part of a team
- PhD in Clinical Research or related field
- 5+ years of experience in clinical research management
- Strong leadership and project management skills
- Excellent problem-solving abilities
- Bachelor's degree in Nursing or related field
- 1+ years of experience in clinical trials
- Strong interpersonal skills
- Ability to work in a fast-paced environment
- Master's degree in Data Science or related field
- 3+ years of experience in data management
- Proficiency in statistical software
- Excellent analytical skills
- Bachelor's degree in Life Sciences or related field
- 2+ years of experience in clinical research
- Strong communication and organizational skills
- Knowledge of GCP and FDA regulations
- Bachelor's degree in Computer Science or related field
- Experience with clinical data management software
- Ability to work independently
- Knowledge of statistical analysis
- Strong communication skills and attention to detail
- Familiarity with GCP guidelines
- Familiarity with clinical trial processes
- Experience in clinical operations or project management
- Strong communication and problem-solving skills
- Experience in clinical trial coordination
- Strong organizational skills and the ability to multitask
- Familiarity with regulatory requirements