CLINICAL RESEARCH ASSOCIATE II - Remote

Monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.

Responsibilities:

• Implement and monitor clinical trials, with minimal oversight, to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines
• Initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
• Record site visit activities, including but not limited to, observations of clinical conduct, instructions/training given to sites, and action items to be completed as required by OPs or other contractual obligations
• Review and verify accuracy of clinical trial data collected, either onsite or remotely, including query resolution
• Facilitate supply management and ensure clinical sites have necessary supplies to conduct studies according to applicable protocols
• Assess IP accountability, dispensation, and compliance at the investigative sites
• Ensure all required training is completed and documented
• Perform essential document site file reconciliation
• Communicate with investigative sites
• Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
• Provide regular site status information to team members, trial management, and updates trial management tools
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
• May be assigned additional Clinical Operations tasks
• Help create a fun, rewarding and collaborative environment
  

What your background should look like:

• >3 years of experience in a Clinical Research environment
• Bachelor’s degree in the Life Sciences or related field highly preferred, or equivalent
• Ability to travel up to 80% of the time
• Ability to instill trust in our customers through a dedicated effort to achieve their goals with quality, speed and efficiency
• Ability to handle difficult situations professionally and maintain a professional and caring demeanor
• Proven ability to collaborate in a team environment and work independently
• Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
• Must be responsible, creative and highly motivated

Works Closely With:

CTAs, Clin Ops Specialists, CRAs, Reg CRA Supervisors, PMs, Dir of Clin Monitoring & Data Management, Sr Mgr of Clin Ops

Competencies