Sr. CRA

Job Description

Job Description

Description:

No visa sponsorship is available. Home base location – Midwestern USA . Able to work remotely and travel frequently (approximately 50% to 60%).

For those history buffs

i-Lumen Scientific™ is an Ophthalmology Bioelectric Stimulation company, whose focused on developing a medical device therapy for patients with vision loss due to intermediate to advanced dry age-related macular degeneration (dAMD). We know, that’s a mouth full!

Who doesn’t want to keep their eyesight? Close your eyes for a moment or look through a pair of glasses with a dark smudge in the middle. A smudge so dark you can’t see through it. Now imagine a day when circumstances change and that’s you. Following that your doctor told you, “that’s just the way it is, and it will only get worse!” Macular degeneration is the leading cause of vision loss for older adults, has no cure, and there are limited treatments options. Our goal is to change that.

Our Mission

i-Lumen ™ is working to change the status-quo by pioneering a new medical device field in ophthalmology intended to improve vision for AMD patients. This new therapy has the potential to address a large unmet patient population in the practice of ophthalmology.

The i-LUMEN™ system and therapy, developed by i-Lumen Scientific, utilizes a revolutionary, non-invasive, medical device, to deliver proprietary pulsed microcurrent stimulation for the treatment of intermediate to advanced dry AMD. You guessed it, with i-Lumen™ technology, there may finally be hope for those with vision loss due to dry AMD.

Are you interested in joining us on this journey? If so, we’d like to tell you a bit more about ourselves.

Our Peeps

Our team includes problem-solvers, car enthusiasts, runners, animal lovers, concert goers, and world travelers who are dedicated to improving vision for those impacted by AMD. The cool thing is, some of us have worked together in the past and we actually like each other. We are passionate about finding great people to join our team. If you are eager to invest your time, talent, and energy in our goal of making the world better one eye at a time, we encourage you to read on!

It’s not just a job

If you been in start-ups you know hat-wearing and communication are keys to success. As we hire, expand and execute a global clinic trial, we need a cohesive team of high performers, who take accountability, know what good looks like and can bring their “A” game each and every day. We don’t do group think, but rather welcome ideas and opinions to ensure the best path forward. Have an idea? Bring it! Have a better more efficient way to get from A to Z? Suggest it! Do you ensure safety and quality of work are uncompromising? Then i-Lumen may be the place for you!

Building for a better tomorrow.

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.

Still interested? Let’s get into the details.

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.

Do you have the following 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.

Think you have what it takes? If we piqued your interest, we hope you will pique ours and follow the prompts to apply!