The Senior Medical Physicist will provide expert medical physics guidance to develop, enhance and implement strategies and procedures which support the site qualification and monitoring process for imaging techniques and support medical affairs and project teams for issues relevant to optimizing and maintaining the integrity of medical imaging and derived data, including but not limited to image acquisition, processing and analysis.
Primary Responsibilities- Participates in imaging protocol design phase for studies using molecular imaging techniques
- Liaises with internal technologist staff and project teams to address protocol specific issues
- Identifies/defines critical data required for site qualification and site quality assurance
- Reviews and recommends/revises documents/forms used internally and externally in the imaging site qualification process
- Assists in defining an escalation plan and providing physicist support for the plan in the event of site qualification failure
- Provides capabilities and project updates regarding medical physics and site qualification programs to Senior Management as needed
- Communicates directly with staff at PET imaging facility, when needed, whether at the initiation of site qualification process or during the trial, for site support
- Provides direction and support to sites which lack expertise to accomplish qualification process
- Communicates with imaging site physicist, as needed
- Collects data at imaging site and perform in-house analysis, when needed
- Performs image measurements of subject studies to provide radiopharmaceutical count data to be used for biodistribution and radiation dose assessments or other quantitative analyses.
- Monitors technical imaging quality of submitted exams during clinical trials
- Assists in development of internal database of Bioclinica-qualified imaging centers
- Reviews current nuclear medicine bone scan QC/QA program and provide support to imaging operations and project teams, as needed
- Communicates directly with sponsor, either individually or as part of Bioclinica team for proposed or active trials
- Provides educational presentations for internal staff and sponsors regarding site qualifications and medical physics issues relevant to imaging protocols
- Establishes and maintain relationships with scanner vendor and scientists for imaging optimization and assistance with technical issues
- Supports efforts to create scientific publications relevant to medical physics issues as they apply to molecular imaging to highlight and enhance the visibility of Bioclinica expertise
- Attends meetings, including investigator meetings, capabilities presentations and scientific meetings as needed
- Addresses issues regarding radiation dosimetry; guidelines and standards to be advocated by the company for imaging sites
- Participates in outside activities as they relate to internal Bioclinica processes and process improvement
- Develops expertise that can be leveraged through speaking engagements to further enhance Bioclinica's visibility as an Imaging Core Lab with Molecular Imaging expertise
- Executes clinical functions as required by the study protocol and according to Good Clinical Practice (GCP) and Bioclinica's Standard Operating Procedures.
- Ensures confidentiality of study protocols and subjects is maintained
- Adheres to project timelines
- Communicates with all customers appropriately and professionally
- Maintains security of images, data and equipment
- Responsible for his/her continuing professional education
- Performs quality control on his/her work for completeness and accuracy
- Documents activities and work according to SOPs. Writes clearly and accurately
- Maintains a safe work environment. Reports workplace hazards immediately
- Other responsibilities as assigned by the Vice President of Oncologic and Molecular Imaging
Secondary ResponsibilitiesMaintains Quality Service and Departmental Standards by
- Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")
- Assisting in establishing and enforcing departmental standards
Contributes to team effort by
- Working with internal staff to resolve issues
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to achieve results
- Performing other duties as assigned
Maintains Technical and Industry Knowledge by
- Attending and participating in applicable company-sponsored training
Qualifications: Education:
- MSc or PhD in Medical Physics, Radiation Physics or related field.
- At least 5 years' experience in Hospital Imaging Department
Experience:
- Prior experience with clinical drug development and regulatory issues in Pharmaceutical or Biotechnology industry
- Experience in defining, evaluating and remediating imaging requirements for multicenter imaging studies preferred
- Teaching experience a plus
Working conditions:Travel: 0-5%
Lifting: 0-10lbs
Other: Computer work for long periods of time
