Senior Director of Quality

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
Summary
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.

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
Position Requirements:
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
Able to adapt and work around limitations of remote monitoring
Supervisory Responsibility
This position does not currently have supervisory responsibilities over other managers
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers, and smartphones.
COVID Policy
Lumicell has an implemented and strictly enforced COVID Policy that is intended to keep all employees safe when working on-site. Our policy mandates: restricted number of employees on-site at a time, a socially distanced and protected seating structure, mandatory mask-wearing, and daily cleaning & disinfection of all communal areas.
Employees are given full flexibility to be able to work on-site and remotely to help limit the amount of person-to-person exposure. On-site vs. remote working percentages will depend on the individual’s responsibilities and project needs.
Lumicell has also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.
Position Type/Expected Hours of Work
This is a temporary full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
Travel
Travel will be expected for this position including hospital site visits, internal meetings, conference and or training events.
EEO Statement
Lumicell is an equal opportunity employer
Other Duties
LPlease 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 careers@lumicell.com.