Supervisor: Clinical Manager
Job Function:
The Senior CRA will assist the Clinical Research Manager in implementing clinical research activities for Emerson Consultants clients. The CRA will perform all assigned study support activities for both pre-market and post-market services in support of client’s products and therapies.
Description of Duties:
The CRA performs the following tasks with minimal supervision:
- Assist in development and preparation of clinical study protocols and case report forms
- Assist in development and preparation of study materials, and training of clinical sites, Emerson Consultants staff, and client representatives on the study requirements
- Assist with clinical site activation including tracking of site activation status, review of informed consent documents and contracts, and review of the adequacy of site activation documentation
- Provide clinical study site support and regular communication with clinical sites during the conduct of the clinical study. Assist with troubleshooting and make recommendations to optimize site compliance and satisfaction with the implementation of the clinical study
- Assist with research and preparation of information for making decisions regarding selection of vendors for clinical services
- Review clinical data/information and oversee data correction and data query process. When vendors are performing services, assist with overseeing vendor’s activities
- Assist in writing sections of the clinical reports
- Monitor clinical sites to ensure compliance with the clinical study protocol and applicable regulations and compliance standards. When vendors are performing services, assist with overseeing vendor’s activities and reviewing the timeliness, accuracy, and completeness of monitoring reports
- Other responsibilities as assigned
- Position may require up to 30% travel
Education, Training and Experience Required:
- Bachelor’s degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field. Masters degree may substitute for 1 year of experience
- Minimum 3 years experience directly supporting clinical research or similar experience in a medical/scientific area. Six or more years of experience may substitute for Bachelor’s degree
- High attention to detail and accuracy
- Self-directed individual, able to take the initiative and handle ambiguity
- Advanced written and oral communications skills
- Able to manage multiple tasks
- Proficient knowledge of medical terminology
- Expertise with GCPs and regulatory compliance guidelines for clinical trials
- Good problem-solving skills
- Familiarity with clinical and outcomes research designs and methods