Will provide hands on support for clinical studies, reporting to Sr. Manager of Clinical Affairs. CRA is responsible for supporting the Clinical Affairs team with pilot and multi-center clinical studies. Position will include but is not limited to the following responsibilities:
- support all functions of clinical studies, from assembly of subject folders, maintenance of Trial Master File, monitoring and data management.
- conduct site qualification, initiation, monitoring and closeout visits to ensure protocol and regulatory compliance, perform source document verification in accordance with ICH-GCP, FDA guidelines and company SOPs.
- support with clinical trial materials such as regulatory binder, CRFs and study logs.
- Participate in internal and external team meetings
- Collect organize and track trial documentation in accordance with company standards and SOPs.
- Coordinate with participating site investigators and coordinators to ensure subject enrollment is on track and the smooth execution of clinical studies.
- help identify potential sites, distribute site questionnaires, collect and review essential regulatory documents.
- Support local IRB submissions, review ICFs for adherence to FDA in 21CFR 50.20.
- Support all other functions related to clinical operations
- Assist in administrative and special projects as required
- Provide data entry and management support as needed.
- Coordinate activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
- Maintain a high level of professional expertise through familiarity with clinical literature and participates in project team meetings.
- Bachelor’s degree in biological or related sciences
- 5 years of clinical study experience with a minimum 3 years of on-site study monitoring experience
- Life science industry experience desirable
- Computer proficiency — MS Windows, MS Office
- Database and electronic data capture experience highly preferred
- Excellent written and verbal communication skills
- Ability to travel up to 70%, including overnight travel, nationwide
- Experience working in clinical trials
- Knowledge in reference to ICH-GCP, FDA 21 CFRs and ability to follow standard operating procedures.
- 25%-60% required travel to field sites.
- Experience with organizing and maintaining trial master files (TMF) preferred
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