Clinical Trial Manager - Part-time

At Lumicell, we will give you the opportunity to harness all that's within you by working in a mission driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. Every two minutes, a person is diagnosed. Our founder, David Lee lost his wife to breast cancer. You will be a part of something groundbreaking as we accelerate our commercial launch.

We are looking for Part-time Clinical Trial Manager to join our team.

What You Will Do:

• 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.

What You Will Bring:

A minimum of 3 years' experience as a Clinical Trial Manager, 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.

Position Type/Expected Hours of Work:

• This is a part-time position. Work hours will be determined upon hire. Expectation is 20-30 hours per week over 3-5 days and mostly between the hours of 8:30-5:30pm.

Lumicell is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.