Sr. Clinical Research Associate

Responsibilities

• Independently schedules and conducts remote and on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for-cause visits.
• Conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/IP/ID storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.
• Documents observations and monitoring activities in a site visit report at the conclusion of the visit with minimal feedback by the report reviewer.
• Facilitates and oversees Action Item resolution post visit.
• Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures.
• Serves as point of contact for study site personnel to answer questions and resolve study-related issues under the direction of the project CRA staff oversight lead.
• May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.
• Prepares for and attends project team meetings and provides updates on project status and site-specific performance.
• Works collaboratively and effectively in a project team environment including internal and external colleagues to meet project objectives and timelines.
• Participates in Investigator Meetings or other client meetings as needed.
• Affords assistance with filing and archiving of study documents.
• Affords assistance with coordination of clinical study supplies.
• Affords assistance with submission of applications/notifications to Institutional Review Board (IRB)/Ethics Committee (EC)/Regulatory Authority.
• Affords assistance with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans.
• Performs site management activities as required.
• Performs other duties as assigned.

Qualifications

• Bachelor's Degree in a scientific discipline or equivalent work experience.
• 4-6 years monitoring experience (on-site and remote).
• Proficient with MS Office Suite.
• Excellent computer and organizational skills.
• Exceptional level of attention to detail required.
• Self-starter who can work remotely and a team player who can work cross-functionally with minimal oversight.
• Expertise in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines, as required per their role as a CRA.
• Excellent organizational, interpersonal, and communication skills both oral and written.
• Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment.
• Expertise in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities.
• Ability to collaborate with internal and external colleagues and work well in a team-oriented setting.