Clinical Research Associate (CRA) / Field Monitor
Position Title: Clinical Research Associate (CRA) / Field Monitor
Position Type: Remote, Full Time Temporary (12 month contract, starting January 2020)
Desired Location: Within driving distance of Houston, TX, Palo Alto, CA, Scottsdale, AZ, or Tacoma, WA
Reporting To: Clinical Research Associate Manager
This full-time, salaried, field monitor position is responsible for the monitoring, management and source data verification of assigned clinical study sites. The field monitor helps ensure the regulatory and scientific integrity of studies by verifying data through on-site visits and remote data monitoring. The field monitor will evaluate, monitor, document study information as defined by the Clinical Monitoring Plan and will use best judgment for problem resolution and providing guidance to clinical sites based on GCP, ICH, and CFR guidelines. This is a temporary role (12 month term with an option for renewal). The field monitor will report to the Clinical Research Associate Manager. This position is a field position with up to 80% travel expected.
Essential Duties and Responsibilities:
- Serve as liaison with participating clinical research sites, including, but not limited to, physician investigators, research nurses, and study coordinators
- Conduct on-site and remote monitoring as needed
- Prepare and submit monitoring documentation per SOPs and Monitoring Plans
- Triage and escalate clinical study issues as needed
- Support clinical research study start-up activities, including training material development, delivery, and documentation
- Function as a resource for trial sites for all study-related issues, including site-related problem identification and corrective/preventive solution development.
- Train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, data entry and query resolution
- Oversight of Trial Master File and Essential Documents. Experience with electronic Trial Master Files preferred
- Communicate with in-house clinical affairs team via participation in scheduled and ad-hoc team meetings
- Additional projects related to the clinical study and data cleaning may be assigned
- Strong understanding of FDA guidelines regarding clinical trials to include GCP and ICH guidelines.
- Excellent and demonstrated oral and written communications.
- Adaptive working style and ability to foster relationships with clinical sites, vendors and colleagues
- Able to manage multiple projects with minimal supervision
- Must have a minimum of two years field monitoring experience working on FDA regulated clinical research
- Device experience preferred
- This position is a field position with up to 80% travel expected.
- Lumicell is an equal opportunity employer
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice
To apply for this position, please send your resume to email@example.com.