Helping patients, pathologists and physicians work together to accelerate and optimize treatment
Deep Lens, Inc, through our next-generation AI technology and cloud-based solutions, are driven to increase cancer cure rates and minimize the side effects of treatment for patients globally.
We value everyone’s unique background and support a work-life balance to bring solutions to market that have a positive impact for health professionals and those individuals impacted by cancer.
The Technology team at Deep Lens, Inc. is seeking an experienced Clinical Research Coordinator Consultant. The focus of this role is on identification and pre-screening of patients for clinical trials. The candidate will assist Deep Lens Network Sites in the coordination with the Site’s Principle Investigators (PI) and Clinical Research Coordination team with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
Roles and Responsibilities
- Assist in the creation and updating of standardized clinical trial tools and processes, SOPs associated with the Deep Lens VIPER platform and overall Patient Recruitment methodology.
- Collaborate with the care team and provide assistance in the development and/or improvement of recruitment and pre-screen strategies.
- Schedule and coordinate study meetings, materials and agendas; aligning objectives and coordinating activities with Deep Lens, the Sites, and Pharma Sponsors.
- Assemble data and complete routine analyses for a variety of reports. Enter data to records or logs and establish and maintain files.
- Manage system level tasks within the VIPER platform to support the Site Clinical Research Team.
- Customer Support point of contact for Deep Lens VIPER; Respond to various inquiries from the Care Team and Clinical Research Team, physicians, telephone callers and visitors by providing information according to guidelines or directing alerts/messages to the appropriate person. May be required to act as liaison between investigational sites/vendors and department management.
- Assemble Clinical Research and Care Team training materials and manage workflow items to increase education where necessary in the process.
- Provide guidance and training to new administrative staff.
- Assist Clinical Lead with reference searches in support of protocol development.
- Identify and resolve administrative project issues.
- Participate and support in pre-study visits, site initiation and study close visits, as appropriate.
- Coordinate and manage version control of clinical documents.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Bachelor’s degree required
- A minimum of 2-years experience in clinical operations or related field required, site CRC experience preferred.
- Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations, including HIPAA policies and procedures, is required. A broad understanding of essential study documentation is critical.
- Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures.
- Knowledge of ICH/GCP and regulatory environments including regulatory documentation review and approval.
- Strong communication and interpersonal/team skills.
- Proficient in MS Excel, Word and PowerPoint.
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
- Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.
- Understanding of clinical trials methodology and terminology
- Ability to work in a self-driven capacity, with a sense of urgency and limited need for oversight
- Client focused approach to work; flexible attitude with respect to work assignments and new learning
- Regional travel required
- Excitement about the vision and mission of Deep Lens, Inc.