Study Startup Specialist
- Coordinates clinical trial start-up activities including the following:
- o Ensures that assigned start-up activities are on track and in accordance with client and internal expectations.
- o Inventory, log, and organize study materials received during study start up.
- o Distribute study materials to delegated individuals while maintaining accountability for the transfer of supplies.
- Collaborates with clinical staff to ensure that studies are conducted efficiently and are completed with the highest quality standards and outcomes.
- Communicates with external vendors including contract research organizations, sponsors and monitors on behalf of clinical staff.
- Review clinical study documentation in adherence to protocol, ensuring compliance.
- Participates in formal training of study staff prior to first subject screening.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
- Must be able to effectively communicate verbally and in writing.
- Must have proper experience and demonstrate mastery of Study Startup Specialist I position.
- Thorough understanding of clinical research terminology, good clinical practices, regulatory and ethical guidelines and regulations.
- One year of experience in clinical research.
- Strong customer service and client relationship skills.
- Excellent organization and time management skills with strong ability to prioritize and multi-task across competing demands.
- Excellent verbal/written communication skills with evidence of effective collaboration across businesses and functions.
- High-level computer skills.
- Indoor, Clinic and Office environment.
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
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