Clinical Research Associate
Position Title: In-House Clinical Research Associate
Position Type: Full Time
A minimum of 3 years’ experience as an in-house Clinical Research Associate, or an equivalent combination of training and experience in clinical research and or a related field, with skills and knowledge working on clinical trials following FDA/ICH guidelines.
Essential Responsibilities and Duties:
- Serve as liaison with participating clinical research sites, including, but not limited to, physician investigators, research nurses, and study coordinators
- Manage site start-up activities including contracts and IRB approvals
- Lead clinical research study start up activities (Includes creation of study binders, study logs, work instructions, case report form, and other study related materials)
- Function as a resource for trial sites for all study-related issues, including site-related problem identification and corrective/preventive solution development.
- Ability to 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.
- Assist with data collection process including with process of ensuring site compliance, patient data integrity, edit checks, query resolution, and resolving data management issues. Experience with electronic data entry preferred.
- Support the design, implementation, and evaluation of recruitment strategies for study participants and ongoing monitoring of accrual rates
- Contribute to preparation of reports and analyses reflecting study progress, enrollment trends and appropriate recommendations and conclusions.
- Support and facilitate monitoring activities
- Understanding of FDA guidelines regarding clinical trials to include GCP and ICH guidelines.
- Excellent and demonstrated oral and written communications.
Position Type/Expected Hours of Work:
- This is a 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.
- Lumicell has an implemented and strictly enforced COVID Policy that’s intended to keep all employees safe when working on-site.
- 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.
- 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 firstname.lastname@example.org.