On-site Clinical Research Associate

Protagonist Therapeutics•Newark, NJ

5d•Onsite

About The Position

Support ongoing trials and/or set-up and manage new trials. Contributions include: study planning and start-up, project, site and vendor management oversight of study site monitoring and performance, and clinical operations input into the general clinical development of Protagonist compounds. Must be willing to be onsite 5 days a week.

Requirements

Clinical trial experience that includes international Phase 1-2 trials, involving CROs from study set-up through to completion.
High level of appreciation and understanding of the feasibility, regulatory and start-up processes, together along with on-site monitoring and site management.
Good overall understanding of the major areas within clinical development.
Excellent communication and interpersonal skills, along with attention to detail and critical thinking skills.
Strong written and spoken English.
Ability to collaborate, problem solve and work in a small dynamic organization with minimal supervision, to achieve personal and collective goals.
2+ years as a CRA within Biotech/Pharma or CRO.
Bachelors Degree.
Experience and proficiency with Good Clinical Practices (cGCP) and compliance with Protagonist SOPs.

Nice To Haves

Experience with Gastrointestinal, hematology and/or orphan drug trials preferred.

Responsibilities

Serves as the internal primary site operations lead, working with the Project Manager and CROs to achieve efficient study set-up and initiation, ongoing data monitoring all the way through successful study execution and site close-out.
Oversight of the site feasibility activities leading to site selection, activation and routine monitoring activities to ensure ongoing data integrity and quality.
Develops and reviews integrated site plans/timelines and reports weekly progress including risks and mitigations.
Develops contingency plans for site performance, with regards to recruitment, data quality etc.
Helps ensure the trial stays within the contracted site management scope, progress, timelines and budget.
Presents site management strategy and status/metrics at project meetings.
Monitors and reports on CRO CRA resource utilization, and analyzes expected vs. actual performance.
Implements and leverages best monitoring practices.
Experience and proficiency with Good Clinical Practices (cGCP) and compliance with Protagonist SOPs.
Works closely and effectively with other cross-functional teams to identify best practices and process improvements.
Proficiency with MS Office computer software.
Other duties and assignments as requested for the overall performance of the function and Company.