Research Assistant

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