Clinical Research Manager jobs in Kentucky

Description

Circuit Clinical® is on a mission to transform the way people find, choose, and participate in clinical research..

We are searching for a part-time or per diem Research Coordinator to join our team!

Circuit Clinical was ranked 20th nationally for Best Workplaces for Innovators by Fast Company® and was named an Inc. Magazine® Best Workplaces 2021. Topping a long list of innovation and startup awards over the last 5 years – including winning SCOPE’s Participant Engagement Award and winning at 43North - Circuit recently won Fast Company’s World Changing Ideas™ Award.

Our award-winning culture is grounded on a belief in the values of transparency, inclusion, accountability, performance, talent seeking, & continuous learning. We live these values every day and we’re looking for a leader who embodies them. Our focus is on building an incredible, hard charging Team and on providing them with the opportunity to do the best work of their careers. In short, we’re motivated to take on the hardest problems in the development of new medicines – this is Work That Matters.

To accomplish our Mission, we know we must recruit the most dynamic, mission-driven, empathetic, and passionate leaders in our industry. That’s where you come in!

What We Offer:

If you’ve been looking for a chance to work with an amazing, highly motivated team and to have direct impact in building a transformative clinical trials company every day – that is exactly what we’re offering. We provide competitive benefits and an environment focused on helping you grow personally and professionally. 

Requirements

What You Will Bring to Circuit Clinical:

As our Research Coordinator, you will be responsible for coordinating, facilitating, and monitoring the implementation of research study protocols being conducted in accordance with departmental policy, institutional policy, sponsor requirements, and FDA regulations. You will also provide, manage, and coordinate care for patients participating in clinical trials in compliance with written study protocols.

You’ll Be Responsible For:

• Having thorough knowledge of study protocol, including inclusion and exclusion criteria and confirmation of subject eligibility
• Knowledge of study endpoints, reportable events (Adverse Event, Serious Adverse Event, Adverse Events of Special Interest)
• Knowledge of disease process and standard of care
• Completion of study screen tool and study summary
• Defining methods of subject identification and recruitment
• Thorough knowledge of protocol to conduct Informed Consent Form process
• Completion of screening procedures, randomization, and subject visits
• Investigational Product dispensing and accountability
• Scheduling of study visits in compliance with protocol(s)
• Preparation and maintenance of source documents and IRB submitted documents for recruitment
• Assisting in recruitment efforts, contacting and identifying potentially eligible participants to screen
• Confirming Primary Investigator review of study visits
• Reviewing Adverse Events and Serious Adverse Event with Primary Investigator within 24 hour of event report to Institutional Review Board (IRB) and sponsor
• Subject retention activities and follow up procedures
• Obtaining consents for amendments where applicable
• Participating in protocol amendment training and updates essential documents accordingly
• Sponsoring monitoring activities, preparation, data clarification
• Weekly review of study status
• Obtaining appropriate certification of required trainings
• Contributing to patient recruitment efforts as business demands require.

Your Qualifications:

• Bachelor’s degree required. 
• Licensed as a registered nurse (RN) or licensed practical nurse (LPN) in the state of Kentucky, preferred.
• Minimum 3 years experience as a Research Coordinator; or one year of RN level nursing, direct patient care in hospital setting or clinical research nurse

Your Preferred Experience:

• Certification of Clinical Research Coordinator, preferred. If no certification, willing to obtain certification within two years.
• Computer literacy including Microsoft office (Word, Excel), Google suite, and CTMS software a plus.

Who You Are:

We prize 4 traits above all others:

Hungry: we like people who are ambitious for themselves AND for our Mission and for each other – we’ll all win together and that takes real drive

Happy: we seek pragmatic optimists – pessimism and ironic dispositions, especially in leadership can kill startups – we seek those who know the world can be improved by those who work hard and smart to change it

Humble: not the false “I’m not really anything” kind of modesty – we like swagger! But we prize people who are confident who know they are great, and so is everyone around them… and act accordingly

Smart: there are a LOT of smart people here… but smart is last for a reason. We want those kinds of smart people who can collaborate and respect the intelligence of others.

What Else Predicts Success and Happiness for you at Circuit?

• Your organizational skills are top notch. You will need to be comfortable handling a great deal of information from various sources including internal and external.
• Your accuracy and attention to detail are among your best qualities - you enjoy the fine print. This is a critical skill in this role.
• You prioritize and focus well. You may be coordinating several studies in tandem and this will require prioritization and focus.
• You enjoy learning about new disease states and are able to understand medical jargon as well as explain in layman's terms to your study participants.
• You enjoy learning new systems and technology.
• You are able take direction from the Principal Investigator, superiors, and teammates.
• You are able to identify problems and escalate issues quickly.
• You have a patient first mentality.
• You have a way of putting the study participants at ease, addressing their concerns in a calm and warm manner.

The Other Fine Print:

Location: This position is located at our Bowling Green, KY site.

Schedule: 8:00 AM - 12:00 PM, 3 days per week. Friday availability is required 

Travel: May require regular travel to other research site locations.

Exemption Status: Part-time or per diem, non-exempt

Physical Requirements: the following physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions: 

Regularly required to stand; walk; use hands; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. 

Occasionally required to sit. Occasionally lift and/or move up to 50 pounds. Specific vision abilities include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.

Other Duties: the duties and responsibilities described are not a comprehensive list and that additional tasks may be assigned to the employee from time to time; or. the scope of the job may change as necessitated by business demands.