The Clinical Lead participates in the development and delivery of clinical products/services related to clinical trials, such as training, surveillance, and cognitive testing. The Clinical Lead interacts with the sponsor to define the deliverables, and may directly participate in their execution through attendance at face-to-face and virtual training events.
Clinical Responsibilities
- Develops project specific video material:
- Prepares project specific clinical content for study staff/patient education videos
- Conducts patient interviews and provides clinical feedback on interviews
- Prepares initial scoring rationale; coordinates scoring by clinical team based on acceptable score range guidelines
- Collaborates with Creative Services staff to edit video material to meet project specific criteria
Develops clinical content for training and qualification programs for study staff in clinical trials:
• Reviews protocol/CRF and provides feedback as appropriate
• Develops and ensures quality of project specific didactic presentations and other project specific clinical deliverables
• Attends internal and external kickoff meetings and project status meetings throughout the life of a project as required
• Attends Investigators’ Meetings to assist with direct execution of training as appropriate
• Develops protocol specific certification methodology
• Proactively identifies and escalates potential project issues appropriately to project team, sponsor and/or manager
Communicates with study site staff to address data quality issues:
- Communicates with study site staff in accordance with project specific methodology/SOPs
- Develops and ensures quality of project specific materials for efficient communication with study site staff
- Documents communication with study site staff in the respective IT application (e.g., RDA, IR2)
Manages reporting and analysis activities:
- Collaborates both internally and externally to ensure appropriate study design
- Develops reporting and analysis plans as appropriate
- Ensures that data-related issues are addressed (e.g., data queries, data amendments)
- Writes and QCs reports and other scientific text
- Ensures that data quality reviews are conducted as defined by project scope
- Ensures consistency of product with actual project scope and resolves ambiguities in collaboration with both internal and external project teams
Conducts remote scoring, interview assessment, and/or central rating:
- Conducts/reviews protocol specific scale interviews with patients (may require flexible schedule to accommodate time zone variations)
- Completes all required documentation within specified timeframe
Assists in training, development and retention of external Clinical Experts based on documented requests from Project Management:
- Participates in training and/or ongoing synchronization of external Clinical Experts (e.g., National Language Experts, Expert Presenters)
- Collaborates with external clinical resources and sponsor to ensure consistency with identified project scope and sponsor expectations
Initiates research activities:
- Prepares and submits poster presentations and journal articles under the guidelines of the Research Steering Committee and presents research at conferences as appropriate
- Submits weekly report of activity to manager
- Participates in orientation and training of staff as appropriate
- Participates on committees as assigned
- Enhances the Specialty Clinical Services business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently
- Supports business development activity as assigned by manager
- Ability to perform all responsibilities of Sr. Clinical Associate if required
Education
- Masters Degree, M.D., Ph.D., Psy.D, Pharm.D., in healthcare-related field, with one year of clinical experience, which includes administration of psychiatric and/or cognitive scales OR
- RN with 3 years of clinical experience, which includes administration of psychiatric and/or cognitive scales OR
- Bachelor’s Degree in healthcare-related field with a minimum of two years of clinical experience, which includes administration of psychiatric and/or cognitive scales OR
Experience
- Minimum of one year clinical experience
