The Senior Clinical Research Associate (Sr. CRA) will support Prothena Clinical Operations through oversight monitoring for CROs and in-house monitoring execution for assigned studies. The Sr. CRA will build strong, collaborative relationships with the Study Management Team, CRO CRAs, and clinical study sites to ensure high quality execution of Prothena studies.
CRO Outsourced Model
· Conduct monitoring oversight visits (MOVs) with CRO CRAs to assess compliance to the protocol and Clinical Monitoring Plan.
· Perform eCRF data review to identify trends, areas of risk, and address findings with site and/or CRO monitor.
· Review Monitoring Visit s from CRO and escalate monitoring trends or findings to Monitoring Operations leadership.
· Participates and provides input on site feasibility, qualification, and selection.
· Coordinates and/or supports tasks in collaboration with the CRO and study team to achieve site activation.
· Provides support and guidance to the CRO CRA team members on monitoring and study-related questions from site selection through closure.
· Reviews and provides input to Clinical Monitoring Plan for assigned studies.
· Act as a point of escalation for resolution of site performance, quality or compliance problems.
· May support the CRO CRAs and CTMs in the implementation of site corrective and preventatives actions, including effectiveness checks.
Insourced Monitoring Model
· Performs onsite or remote monitoring activities efficiently in compliance with FDA/GCP/ICH requirements, SOPs, local laws and regulations, protocol, Clinical Monitoring Plan, and associated documents.
· Conducts site visits including but not limited to qualification visits, initiation visits, interim monitoring visits, close-out visits, and generates clear, comprehensive, and accurate visit s and letters in a timely manner.
· Executes all aspects of monitoring accurately and effectively, including source document and CRF review, informed consent verification, data query resolution, investigational product accountability and essential document management.
· Trains and assists site coordinators and investigators in collecting data and executing the study in a timely, compliant manner; serves as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols; monitor and track study progress; and resolve obstacles.
· Communicates and documents contacts with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
· May act as a monitoring subject matter expert; participate in department initiatives and provide training on operational tasks to Prothena team members
· May conduct CRA assessment visits as needed.
· Contributes to and/or supports site audit/inspection preparation activities as needed.
· Completes routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense submissions and approvals as needed).
· Performs other related duties and responsibilities, as assigned.
Education and/or Experience
· Bachelor’s degree in scientific discipline required; master’s degree or higher is a plus.
· At least 6 years’ experience in the role of Clinical Research Associate in biotech / pharma companies and/or CRO, including conduct of start-up, execution, and close-out activities related to clinical studies.
· Experience monitoring Phase 1-3 clinical trials; experience in first in human trials is a plus.
· Knowledge and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements.
· Neuroscience, oncology, and/or rare disease therapeutic experience preferred.
Competencies and Attributes
· Demonstrated ability to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful.
· Demonstrates critical thinking, root cause analysis and problem solving to identify site process failures; develop corrective and preventative actions to bring sites into compliance
· Ability to motivate clinical site personnel to compliantly maintain/accelerate timelines to achieve clinical operational milestones.
· Proactively identifies and mitigates risk.
· Strong verbal and written communication and negotiation skills with the ability to work collaboratively.
· Advanced organizational skills along with strong attention to detail and time management proficiency.
· Able to work independently and effectively provide oversight and support to CRO CRAs.
· Ability to travel domestically approximately 60% of working time.
· Maintains computer literacy in Microsoft tools and clinical study software applications.
Job Type: Contract
Pay: $50.00 – $80.00 per hour
Work Location: Remote