Note: The job is a remote job and is open to candidates in USA. reputed company. is an ophthalmology bioelectric stimulation company developing a medical device therapy for vision loss caused by dry age-related macular degeneration. The Senior Clinical Research Associate will support clinical study execution and monitoring from start-up through close-out, ensuring compliance with regulations, Good Clinical Practice, protocols, and company procedures.

Responsibilities

• Work under minimal guidance and participate in the conduct of clinical research projects and protocols, contributing technical and clinical expertise
• Contribute to the execution of clinical trials in terms of all operational aspects of study start-up through close-out including supplying study materials to sites
• Participate in the preparation of clinical study specific training materials, as needed
• Support the administration of clinical studies according to good clinical practices (GCP) and standard operating procedures (SOPs), which may include management of communications with contract vendors, CROs, clinical study team, and clinical sites
• Review study documentation for accuracy and completeness in accordance with protocol, GCP, and regulatory requirements
• Maintain study documentation within the Sponsor Trial reputed company File (TMF) and other study management systems, tracking, and reporting trends to the clinical team
• Participate in the evaluation and selection of Investigators and study sites, including site qualification and site initiation visits
• Perform site monitoring visits including close-out (on-site and remote) in accordance with the Clinical Monitoring Plan (CMP) to ensure compliance with the Protocol, applicable regulations, EC, GCP, and i-reputed company SOPs, guidelines, and policies
• Communicate visit findings with site personnel, including a follow-up letter for distribution to the Principal Investigator (PI) and appropriate site personnel
• Prepare site visit reports and correspondence for all visits conducted in accordance with the CMP
• Identify site needs and provide solutions to facilitate the clinical study process
• Act as primary point of contact for study sites as requested
• Assist in reputed company and ongoing site personnel training, as required, including case support and training of clinicians in use of study device(s)
• Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, GCP, and SOPs
• Collaborate with study team personnel and i-reputed company Clinical Team to secure Investigator compliance and provide solutions if needed
• Participate in development and ongoing review of CMP and monitoring tools and resources
• Collaborate with the Clinical and Recruitment Team on the development of patient recruitment materials
• Engage with sites on the internal recruitment procedures and identification of study participants
• Ability to travel approximately 50%-60%
• Other duties as assigned

Skills

• No visa sponsorship is available
• Home base location – in or around Chicago, Illinois or Detroit, Michigan area
• Able to work remotely and travel frequently (approximately 50% to 60%)
• Seven (7)+ years clinical research study monitoring for medical device or related experience
• BS degree or equivalent experience
• Knowledge of federal and local regulations and policies pertinent to research involving human subjects
• Knowledge of ICH GCP and Declaration of Helsinki
• Excellent communication, interpersonal and organizational skills
• Ability to collaborate in a team environment as well as work independently
• Self-starter with the ability to manage multiple projects in a dynamic environment
• If you live in or around Chicago, Illinois or Detroit, Michigan area
• Experience in an Ophthalmology indication is highly preferred

Benefits

• Able to work remotely

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