Provides site management and monitoring support for sponsored clinical studies; primarily Phase I and II, with limited Phase III and IV.
Performs on-site pre-study/qualification, initiation, routine, and close-out visits. Prepare site visit reports and provide assistance to site staff in resolving deficiencies.
Educates and trains site and study staff in management of sponsored studies, including assurance to regulatory and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) compliance.
Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
Assist in protocol, Informed Consent, and CRF design and review.
Develops and demonstrate understanding of and apply therapeutic area knowledge to assignments and project-related issues.
Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.
Decisions are made independently and with some supervision from Director, Clinical Operations/Project Management or Project Manager.
Tasks are primarily intellectual and require exercise of discretion and independent judgment.
Job Requirements Requirements:
BS/MS/RN or equivalent in scientific or health care field; CRC experience a plus.
Four years of pharmaceutical, clinical, or biological research experience with 2-3 years of CRA experience
Working knowledge of SOPs along with Food and Drug Administration and ICH/GCP guidelines.
Good communication, organizational, and writing skills.
Develops and applies efficient computer tools to carry out job functions.
Attention to detail, ability to work in a team environment.
Dependable, assumes responsibility and accepts, supports, and positively facilitates change.
Ability and availability to communicate with sites in different US time zones.
Has the ability to travel (on avg. 50% of time), including international travel.
This job has expired.
Provide an email, zip code for jobs, and/or job category to subscribe to job alerts. Learn more now.
According to the US Bureau of Labor Statistics (BLS), employment in life, physical, and social science occupations is projected to grow 5 percent from 2019 to 2029, faster than the average for all occupations, and will result in about 68,200 new jobs. Increasing demand for expertise in the sciences, particularly in occupations involved in biomedical research, psychology, energy management, and environmental protection, is projected to result in employment growth.
According to BLS, the median annual wage for life, physical, and social science occupations was $69,760 in May 2020, which was higher than the median wage for all occupations of $41,950.
Here are some occupations within Science and Research: