[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
  • For cause visits
• Conducts Informed Consent (ICF) review, source data verification, and compliance reviews.
• Documents observations and monitoring activities in a site visit report.
• Facilitates and oversees Action Item resolution post-visit.
• Ensures compliance with protocol, clinical investigational plan, SOPs, ICH GCP, and other regulations.
• Provides training and retraining to site staff.
• Identifies areas for follow-up and improvement at clinical study sites.
• Serves as point of contact for study site personnel.
• May assist with the development and review of study-related materials.
• Prepares for and attends project team meetings.
• Works collaboratively in a project team environment.
• Participates in Investigator Meetings or other client meetings as needed.
• Assists with filing and archiving of study documents.
• Assists in preparing sites for audits.
• May assist with coordination of clinical study supplies.
• May assist with submission of applications to Institutional Review Board (IRB) or Ethics Committee (EC).
• 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.
• 1-3 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 and ICH guidelines.
• Excellent organizational, interpersonal, and communication skills.
• Demonstrated problem-solving skills and adaptability.
• Knowledgeable in prioritization, problem-solving, organization, and time management.
• Ability to collaborate with internal and external colleagues.

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