Job Description

Purpose
The Clinical Research Associate (CRA) is responsible for overseeing the operational aspects of clinical trial conduct at investigational sites to ensure data integrity, regulatory compliance, and adherence to Good Clinical Practice (GCP) guidelines. This role supports multiple clinical trials across various therapeutic indications and is instrumental in monitoring site performance, resolving issues, and facilitating communication between sponsor and site personnel.

• 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
• Coordinate 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
• Start job responsibilities punctually and ensure consistent presence throughout the entire shift to complete responsibilities properly and attend all scheduled meetings and appointments
• 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

Skills

• In-depth understanding of ICH-GCP, FDA regulations, and clinical research methodology
• Strong organizational and problem-solving abilities with an eye for detail
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)
• Effective verbal and written communication skills
• Ability to work both independently and collaboratively in a fast-paced environment
• Capacity to manage travel and multiple site relationships simultaneously
• Demonstrated ability to work independently and in a team environment
• Proficiency with MS Office (Word, Excel, PowerPoint)
• Excellent oral and written communication skills and strong organizational abilities

Qualifications/Requirements

• Bachelor's degree (BA/BS) at minimum. Clinical research or life science degree preferred, can have relevant experience as a Physician Assistant, Nurse, EMT, and such
• 3+ years of relevant experience, preferred with at least two years of experience in industry or has worked with Sponsor companies as a clinic coordinator required
• Prior experience as a Sponsor required
• Prior study supervision experience required
• Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred
• Demonstrated working knowledge of GCP-ICH guidelines, and FDA regulations
• Clearance of favorable background investigation required

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