Clinical Trial Associate
Position Title: Clinical Trial Associate
Position Type: Full Time
Job Type: Experienced
Position Type: Senior Director Clinical Affairs
Lumicell is seeking a highly motivated Clinical Trial Associate to work in a dynamic, fast-paced start-up environment. This is an exciting opportunity to join a company that has received excellent press and generated outstanding clinical data from multiple cancer indications. Lumicell is currently conducting a Pivotal trial (similar to a Phase III drug trial) in our lead indication of breast cancer.
This position will support all aspects of the clinical trial program, including Feasibility/Phase I/Phase II studies through Pivotal/Phase III studies in multiple cancer indications for to support PMA and NDA market applications for our combination product (device/drug).
- Timely collection, review, management and filing of all essential clinical documents and communications; including maintenance of site Trial Master File and reconciling site regulatory binders as appropriate. Experience with electronic Trial Master Files preferred.
- Support clinical research study start up activities (Includes creation of study binders/e-binders, study logs, work instructions, case report form, and other study related materials)
- Support the design, implementation, and evaluation of recruitment strategies for study participants and ongoing monitoring of accrual rates.
- Support the monitoring of the study budget, including the support of preparing clinical trial payments in conjunction with the Finance team
- Serve as liaison with participating clinical research sites, including, but not limited to, physician investigators, research nurses, and study coordinators.
- Function as a resource for trial sites for all study-related issues, including site-related problem identification and corrective/preventive solution development.
- 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.
- Serve as the primary point of contact and administrator for clinical trial systems including but not limited to CTMS and eTMF
- Support tracking and implementation of Patient Reported Outcome data for multiple studies
- Support clinical team with Quality Management System (QMS) administration including but limited to updates to documents and SOPs as needed, implementation and tracking of training programs, audit finding resolution and tracking, etc.
- Effective and professional communication skills
- B.A. or B.S. in a science related/health field or related work experience is helpful.
- Proven ability to use all MS Office suite programs
- Demonstrates a working knowledge of ICH GCP regulations
- A minimum of 2 years’ experience as a Clinical Trial Assistant, 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
- This position does not currently have supervisory responsibilities over other managers.
- This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones.
- 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.
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.
- Some travel may be expected for this position including internal meetings, conference and or training events.
- 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.