[Hiring] Senior Clinical Research Assistant @I-lumen Scientific Inc

Role Description

i-Lumen is seeking a Senior Clinical Research Associate (Sr. CRA) located in the Midwest to participate in activities to support the execution of clinical studies to ensure compliance with applicable regulations, Good Clinical Practice (GCP) Guidelines, and i-Lumen Scientific’s Standard Operation Procedures (SOPs).

As a start-up, we are a small team but growing. This means a fast-paced, think on your feet, being accountable and someone others can rely on kind of environment. We don’t have every bell and whistle in our quiver and we create things as we go, ensuring safety and quality in all we do. We do not compromise excellence and depend on each other to do what we say we will do.

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 Master File (TMF) and other study management systems, tracking, and reporting trends to the clinical team.
• Clinical monitoring activities may include the following:
• 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-Lumen 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 initial 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-Lumen Clinical Team to secure Investigator compliance and provide solutions if needed.
• Participate in development and ongoing review of CMP and monitoring tools and resources.
• Support in recruitment activities which may include the following:
• 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.

Qualifications

• Seven (7)+ years clinical research study monitoring for medical device or related experience.
• Experience in an Ophthalmology indication is highly preferred.
• 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.

Benefits

• 401(k)
• Competitive salary
• Dental insurance
• Health insurance
• Paid time off
• Stock options plan
• No visa sponsorship is available.