[Hiring] Senior Clinical Research Associate @Emmes Group

Role Description

The Senior Clinical Research Associate (CRA) is responsible for monitoring clinical study sites either on-site at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs, applicable regulations, and ICH GCP.

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, and compliance checks for required reporting/tracking of adverse events and protocol deviations.
• Reviews investigator site file, laboratory tour, specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour, and storage condition assessment.
• Documents observations and monitoring activities in a site visit report with minimal feedback from the report reviewer.
• Facilitates and oversees Action Item resolution post-visit.
• Ensures compliance with protocol/clinical investigational plan, SOPs, ICH GCP, and other applicable regulations at clinical sites.
• Provides training and retraining to site staff under direction from the project CRA staff oversight lead.
• Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to project CRA staff oversight lead.
• Serves as point of contact for study site personnel to answer questions and resolve study-related issues.
• May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plan, and monitoring documents.
• Prepares for and attends project team meetings, providing updates on project status and site-specific performance.
• Works collaboratively and effectively in a project team environment to meet project objectives and timelines.
• Participates in Investigator Meetings or other client meetings as needed.
• Assists with filing and archiving of study documents.
• Assists in preparing sites for audits and may provide support during audits/inspections.
• May assist with coordination of clinical study supplies.
• May assist with submission of applications/notifications to Institutional Review Board (IRB)/Ethics Committee (EC)/Regulatory Authority.
• May assist 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.
• Complies with all policies and standards.

Qualifications

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

Company Description