Clinical Research Associate

Responsibilities

• Evaluate clinical trial resourcing requirements for qualification (SQVs), training (SIVs), monitoring (IMVs) and support of sites during the conduct of the trials
• Work with multiple trial sites and multiple studies of varying indications simultaneously
• Develop and maintain a monitoring plan for assigned clinical trial(s)
• Liaise with external clinic and/or hospital investigators and associated staff conducting the trial as required to ensure the study and monitoring activities are meeting expectations from start of study to end
• Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study
• Oversee site activation process for each study
• Develop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to study
• Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring
• Track patient enrollment and recommend solutions to trial site staff to increase appropriate enrollment of qualified subjects
• Provide support for the processing of data queries, deviations, adverse events, etc
• Write monitoring visit reports
• Develop and execute a plan to close trial sites on completion of the trial and perform associated closeout activities
• Ensure adherence to ICH-GCP, Standard Operating Procedures (SOPs), IRB regulation, and study protocols
• Ensure adherence for regulatory compliance of investigational sites with SOPs, FDA regulations, and ICH guidelines
• Cover coordination with team data management activities
• Generate protocol and Informed Consent drafts for management review
• Create Literature Reviews for new study indications
• Assist with CRF development
• Assist with investigator meetings
• Create study status data tables and slide decks for upper management review
• Create and maintain study site investigator binders from study start to end
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
• Perform other duties as assigned

Qualifications/Requirements

• Bachelor's degree required, preferably in Clinical Research, Life Sciences or a related field
• Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred
• 3 years of relevant experience in industry or has worked with Sponsor companies as a clinic coordinator required
• Prior study supervision experience required
• Clearance of favorable background investigation required
• Valid Class “C” drivers license
• Up to 50% of travel is required for this role