The Project Manager will support the practice director and manager by managing the tactical and administrative aspects of product development.
Study Coordinator
POSITION RESPONSIBILITIES
- Work with the Principal Investigator on multiple ongoing research studies to coordinate the daily activities/ components of research, including but not limited to:
- Recruit research participants, schedule visits and perform follow-up
- Coordinate data safety monitoring and produce regular reports
- Oversee adherence to research protocols in obtaining informed consent, data collection and management and participant confidentiality
- Ensure that project adheres to the protocol and that clean data is available for data analysis
- Maintain ongoing investigational drug accountability
- Assist with picking up and disbursing investigational drug and provide patient teaching regarding administration, as necessary
- Collaborate with the study team, including internal and external parties, sponsors, PI, and study participants
- Support the regulatory staff in the maintenance of regulatory documents
QUALIFICATIONS & REQUIREMENTS
- Experience and Educational Background - Bachelor’s degree plus 2-3 years related experience is required. Master’s degree is preferred, but not required.
- Candidates must have at least two years of experience in a clinical research environment
- Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts
- Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures
- Proficiency in MS Word, PowerPoint and Excel, electronic health systems and databases used in research environment
- Speaks clearly and expresses self well in one-on-one conversations and groups
- Develops effective written communications and uses them appropriately
- Interacts and proactively shares information with internal and external contacts where appropriate
- Assumes responsibility to ensure issues/concerns will be addressed and monitors them through conclusion
- Able to work independently with minimal supervision
- Experience working with children and minors
- Some travel may be required between our two campuses
Email CV and cover letter to emilysachs@spectrumneuroscience.org for further information.