Clinical Operations Specialist
Biofusion · Austin, TX · Yesterday
AnalystFull-time
Multiple roles are available within clinical operations and research. Below are the key responsibilities, requirements, and qualifications for each position.
Clinical Operations Specialist
Responsibilities
- Support the operational aspects of clinical trials
- Manage trial logistics and ensure compliance with protocols
- Assist with data collection and facilitate smooth trial execution
- Support clinical operations in various projects
- Assist in the development of operational strategies
- Monitor project timelines and deliverables
- Collaborate with external vendors
- Coordinate daily operations of clinical trials
- Assist in patient recruitment and retention
- Maintain study documentation and records
- Facilitate communication between teams
Requirements
- Bachelor’s degree in Life Sciences, Health Sciences, Nursing, or a related field
- 1–2+ years of experience in clinical operations, clinical trials, or project management
- Strong communication, organizational, and multitasking skills
- Ability to work independently and as part of a team
- Familiarity with clinical trial processes, GCP, and FDA regulations is a plus
Clinical Research Manager
Responsibilities
- Lead and manage clinical research projects
- Develop study protocols and budgets
- Ensure compliance with ethical standards and regulatory requirements
- Mentor junior staff and researchers
- Oversee a team of researchers and coordinate with external partners
- Manage regulatory submissions
Requirements
- PhD or Master’s degree in Clinical Research, Life Sciences, or a related field
- 5+ years of experience in clinical research management
- Strong leadership, project management, and problem-solving skills
- Ability to work in a fast-paced environment
- Knowledge of clinical trial regulations is essential
Clinical Trial Coordinator
Responsibilities
- Manage the day-to-day operations of clinical trials
- Coordinate study logistics and manage budgets
- Ensure compliance with protocols and regulatory requirements
- Serve as the primary contact for study participants and site staff
- Monitor patient recruitment and data collection
- Coordinate with investigators and site staff
Requirements
- Bachelor’s degree in Life Sciences, Nursing, or a related field
- 1–2+ years of experience in clinical trial coordination
- Strong organizational, communication, and multitasking skills
- Familiarity with regulatory requirements is a plus
Clinical Data Manager
Responsibilities
- Oversee data management processes for clinical trials
- Ensure data integrity, accuracy, and compliance with regulatory standards
- Collaborate with cross-functional teams to develop data management plans
- Prepare data reports for stakeholders
- Oversee data entry processes and validation
Requirements
- Master’s or Bachelor’s degree in Data Science, Computer Science, or a related field
- 3+ years of experience in data management, preferably in clinical trials
- Proficiency in statistical software and clinical data management tools
- Strong analytical and problem-solving skills
- Ability to work independently
Clinical Research Associate
Responsibilities
- Oversee clinical trials from initiation to completion
- Ensure compliance with regulatory requirements (GCP, FDA)
- Monitor study sites and conduct site visits
- Maintain study documentation and records
- Collaborate with cross-functional teams to ensure timely project delivery
Requirements
- Bachelor’s degree in Life Sciences or a related field
- 2+ years of experience in clinical research
- Strong communication, organizational, and attention to detail
- Familiarity with GCP guidelines is a plus