[Hiring] Clinical Research Associate II @Emmes Group

Role Description

The Clinical Research Associate (CRA) II is responsible for monitoring clinical study sites either onsite 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.

• 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.
• Documents observations and monitoring activities in a site visit report at the conclusion of the visit.
• Facilitates and oversees Action Item resolution post-visit.
• Ensures compliance with protocol, clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.
• Provides training and retraining to site staff including protocol, GCP GDP, and other training.
• Identifies areas requiring follow-up and improvement at each clinical study site and reports findings.
• 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 and monitoring documents.
• Prepares for and attends project team meetings and provides updates on project status and site-specific performance.
• Works collaboratively 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), and Regulatory Authority.
• May assist with site recruitment oversight activities.
• Performs site management activities as required.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's Degree in a scientific discipline preferred or equivalent work experience.
• 1-2 years of relevant monitoring experience (on-site and remote).
• Proficient with MS Office Suite.
• Excellent computer and organizational skills.
• High level of attention to detail required.
• Ability to work on varying projects and exercise critical thinking.
• Self-starter who can work remotely and a team player.
• Knowledgeable in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines.
• Excellent organizational, interpersonal, and communication skills both oral and written.
• Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment.
• Knowledgeable 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.

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment