ABOUT THE ROLE
This role will assist with the coordination of research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to work closely with Topography’s partner healthcare groups. This role will be evaluated on patient experience, protocol management and adherence, and data quality. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country.
KEY RESPONSIBILITIES
Act as research assistant to clinical trials conducted within physician practices, including but not limited to:
Visit preparation activities
Visit follow-up activities
Supply and inventory coordination
Third party vendor coordination
Patient recruitment and identification
Assist with patient study visits
Assist with clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc.
Assist with the informed consent process with care and quality
Adhere to study protocol and GCP
Provide high quality source data capture and documentation
Supporting the IP distribution and accountability process
Adverse Event tracking and follow-up
Data entry to CRF/EDC and query resolution
Protocol deviation tracking, reporting, and reconciliation
Attending sponsor visits including SIVs, IMVs, and COVs, as needed
Use and help improve Topography’s proprietary tool set
Understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs
Follow the study protocols
Maintain meticulous accuracy in completing all documentation
Any other duties assigned by manager
MINIMUM QUALIFICATIONS
High School Diploma or Equivalent
Knowledge of FDA regulations and ICH/GCP guidelines
Ability to draw blood, run labs, take vitals
Strong communication skills, teamwork, cooperation, self-awareness, and flexibility