Clinical Operations Lead

About the Opportunity
We are seeking a Clinical Operations Lead to work in our corporate office, located in Bethesda, MD. The ideal candidate will join the Clinical Affairs Team to support the research and development activities by managing clinical studies in support of BrainScope’s neurotechnology.  The role also assists on the commercial side of the business in support of the commercially available BrainScope One medical device.

  • Reports to Vice President, Clinical Affairs
  • Full Time position
  • Competitive salary, strong benefits and stock options complete the package
  • Travel is required approximately 30% of the time

Key Responsibilities

  • Work creatively with research sites in the areas of hospital Emergency Departments, Urgent Care Centers, US Military locations and Athletic Sports to facilitate and supervise the conduct of clinical trials, build relationships, and effectively communicate ideas and results as an integral member of the Clinical Affairs team
  • Participate in the identification of potential investigators and clinical sites, collect and review data, and prepare evaluative reports
  • Managing study start-up, conduct, and close-out activities to execution within established timelines
  • Conduct clinical site initiation visits; advise and train site personnel on protocol and regulatory requirements for study conduct; arrange, participate in and/or conduct site meetings and multi-center investigator meetings
  • Provide onsite medical device training involving training research staff
  • Conduct remote and on-site monitoring visits to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with applicable regulations, guidelines and policies
  • Review and audit remote and on-site files and records, clinical report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies and discrepancies; provide remedial training and/or initiate corrective action as required
  • Leverage appropriate on going data review to identify and mitigate study design, data integrity or study conduct issues
  • Develop, maintain, and execute Data Monitoring Plans for all studies and trials
  • Follow established procedures and SOPs; seek ways to improve and streamline processes to support the company; provide feedback for opportunities to improve processes or set best practices
  • Assist with protocol activities ensuring adherence to Good Clinical Practice (GCP), regulatory agency guidelines, and overall protocol clinical objectives for all phases of clinical trials
  • In-house management of clinical site reporting (monitoring, complaint handling, study enrollment metrics, etc)
  • Work with other company disciplines (e.g., Commercial, Engineering, Algorithm, and Regulatory/Quality Assurance) to support product development, product implementation (including training) with customers and company objectives
  • Assist with QMS activities that relate specifically to the Clinical Affairs Team
  • Provide oversight and direction to CROs/Vendors when applicable
     

Required Qualifications

  • Bachelor’s degree (minimum), preferably in Life Sciences
  • Minimum of 5 years monitoring experience with CRO or sponsor company preferred; minimum of 7 years of total experience in a clinical research setting required
  • Outstanding organizational skills, attention to detail, planning and prioritizing, efficient time management, concern for quality, common sense and flexibility

Preferred Qualifications

  • Medical device monitoring experience strongly preferred
  • Travel requirements: Up to 30% travel; must be able to work weekends when necessary to meet the needs of our clinical sites and customers
  • Demonstrated exceptional written and oral communication skills
  • Strong computer skills: Experience with Microsoft Office Suite, ability to learn new technology and systems
  • Operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development
 
 

Qualified applicants are encouraged to send their resume and a cover letter including availability to recruiting@brainscope.com. 


 

The Office of Federal Contract Compliance Programs (OFCCP) has released a Voluntary Self-Identification Form CC-305. All federal contractors are required to use this form in inviting all applicants and employees to provide information regarding their disability status. Completing this form is voluntary and any answer you give will be kept private and will not be used against you in any way. If you choose to complete the form, please attach it with your job application. The form can be found at https://www.dol.gov/ofccp/regs/compliance/sec503/Self_ID_Forms/VoluntarySelf-ID_CC-305_ENG_JRF_QA_508c.pdf