Associate Clinical Research Manager
On-siteAustin, Texas, United States
Job Summary
Oversee organization and accuracy of project documents while actively participating with senior team members to meet project needs, projections, and deadlines. Provide support for study conduct by working directly with study monitors and subjects, managing data entry, source data QC, EDC query resolution, lab data verification, and subject eligibility notifications. Act as a liaison between senior project team members, sponsors, investigators, and research teams to facilitate communication. Work in an office or clinical environment with potential exposure to biological fluids, requiring personal protective equipment. Assist management in understanding departmental needs and improving processes.
Required Qualifications
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
- Basic knowledge of Phase I processes and clinical study operations
- Fundamental knowledge of FDA regulations and ICH GCP guidelines
- Basic computer skills with working knowledge of Microsoft Office applications
- Time management and multi-tasking skills
- Written and verbal communication skills
- Ability to prioritize workload and adapt to changing study needs
- Ability to act as a liaison between external and internal groups
- Personal protective equipment required such as protective eyewear, garments and gloves
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