Quality Assurance Manager
Biofusion · New York, NY · Yesterday
Quality AssuranceFull-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
Requirements
- Bachelor’s degree in Life Sciences or a related field (preferred)
- Experience in clinical operations or project management
- Strong communication and problem-solving skills
- Familiarity with clinical trial processes
- 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
Clinical Research Manager
Responsibilities
- Lead and manage clinical research projects
- Develop study protocols and budgets
- Ensure compliance with ethical standards and regulatory submissions
- Mentor junior staff and researchers
- Oversee a team of researchers and coordinate with external partners
- Ensure adherence to timelines and budgets
Requirements
- Master’s degree in a relevant field (required)
- 5+ years of experience in clinical research management
- Strong leadership and project management skills
- Ability to work in a fast-paced environment
- Knowledge of clinical trial regulations
- PhD in Clinical Research or related field
- Excellent problem-solving abilities
Clinical Trial Coordinator
Responsibilities
- Manage the day-to-day operations of clinical trials
- Coordinate study logistics and manage budgets
- Ensure compliance with protocols
- Serve as the primary contact for study participants and site staff
- 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 a relevant field
- Previous experience in clinical trial coordination (preferred)
- Strong organizational skills and ability to multitask
- Familiarity with regulatory requirements
- 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
Clinical Data Manager
Responsibilities
- Oversee data management processes for clinical trials
- Ensure data integrity and accuracy
- Collaborate with cross-functional teams
- Prepare data reports for stakeholders
- Responsible for data collection, validation, and analysis for clinical trials
- Develop data management plans and oversee data entry processes
- Ensure compliance with regulatory standards
Requirements
- Bachelor’s degree in Computer Science or a related field (required)
- Experience with clinical data management software
- Strong analytical skills and ability to work independently
- Knowledge of statistical analysis (preferred)
- Master's degree in Data Science or related field
- 3+ years of experience in data management
- Proficiency in statistical software
Clinical Research Associate
Responsibilities
- Oversee clinical trials and ensure compliance with regulatory requirements
- Monitor study sites and conduct site visits
- Maintain study documentation
- Collaborate with cross-functional teams to ensure timely project delivery
- Manage clinical trials from initiation to completion
- Coordinate with investigators and site staff
- Monitor patient recruitment and data collection
Requirements
- Bachelor’s degree in Life Sciences or a related field
- Minimum of 2 years of experience in clinical research (preferred)
- Strong communication skills and attention to detail
- Familiarity with GCP guidelines
- Knowledge of GCP and FDA regulations
- Strong organizational skills