Circuit Clinical® is on a mission to transform the way people find, choose, and participate in clinical research by building one of the largest integrated research organizations in the U.S and through our award-winning patient experience platform, TrialJourney®.
We are searching for a Lead 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 transparency, inclusion, accountability, performance, talent seeking, & continuous learning. 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 have to 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 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.
What you’ll do: As the Lead Clinical Research Coordinator you will be responsible for managing and coordinating the onboarding of new research sites within your assigned district. You will function as a Research Coordinator on select studies at the sites and have direct oversight of site research staff including coordinators and assistants. You will be involved in the early stages of business development for potential clinical trials and the coordinating and monitoring of the implementation of awarded research study protocols being conducted in accordance with departmental policy, institutional policy, sponsor requirements, and FDA regulations. You will work to create a successful clinical operations environment for sponsors, patients, physician investigators, and the company.
Responsibilities: Clinical Leadership capacity:
- Work collaboratively with Clinical Operations for the onboarding of the new clinical research sites within your district, ensuring the site has all tools, technology, equipment, and staffing
- Provide direct managerial oversight of the research site staff including coordinators and assistants
- Provide direct oversight of all active studies at each site
- Participate in Clinical Operations planning meetings, providing clinical knowledge and support in study selection as well as new projects as presented by senior management
- Provide weekly study status updates to leadership and study teams
- Managing schedule for the clinical team
- Ownership of critical weekly inputs to the financial forecast for clinical projects
- Drives metrics based performance from the team
- Cross-trains on all of our clinical services and contributes wherever there is a need.
Responsibilities: Research Coordinator capacity:
- Knowledge of study inclusion and exclusion criteria, protocol, and amendment training
- Knowledge of disease process and standard of care
- Define methods of subject identification and recruitment
- Knowledge of study endpoints, reportable events (Adverse Event, Serious Adverse Event, Adverse Events of Special Interest) Completion of study screen tool and study summary
- Maintain Administrative Binder, Investigational Product accountability, Pharmacy binder
- Subject Recruitment and confirm subject eligibility
- Study presentation and Informed Consent Form process with Primary investigator and sub investigators
- Completion of screening procedures, randomization, and subject visits
- Investigational Product dispensing and accountability
- Scheduling of study visits in compliance with protocol(s)
- Preparation of source documents and review with investigator
- Subject retention activities and follow up procedures
- Maintain source documentation
- Act as liaison between sponsor/CRO from Pre-Site Visit (PSV) through to Site Initiation Visit (SIV)
- Maintenance of trainings including GCP and IATA
Who you are:
- You love living in the nitty gritty details. This position will require a good amount of detail oriented work. Dotting i’s and crossing t’s is your specialty.
- Your project management skills are stellar - and your follow through is even better.
- You are organized - you know where things are, what needs to be done, and have a system for ensuring things are in their place.
- You are comfortable being in a position of middle management. You can manage up and down while staying grounded.
- You are comfortable delegating tasks when needed and ensuring your team is following through on their deliverables.
- You are a good communicator - you will need to be an effective communicator to clients, staff, and leadership.
- You thrive in a team based environment and are willing to lend a hand when needed.
- You value what we value - transparency, accountability, performance, and continuous learning.
Your qualifications: Bachelor’s degree required Licensed as a RN in the state of Kentucky is strongly preferred but not required 5+ Years of Clinical Research experience as a Research Coordinator or Leader
Your preferred experience:
3-5 years working in a clinical or healthcare setting, preferably as a RN (but not required)
Clinical Research Coordinator Certification preferred or willing to become certified within 2 years of employment
3-5 years of proven success in a leadership role
Proficient with Microsoft Office
Knowledge of EMR systems
Knowledge of CRM
Knowledge of CTMS a plus
The other important details: Location: This position is based at our Pottstown, Pennsylvania Site with occasional regional travel. Exemption status: Full time, 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 sit; use hands; reach with hands and arms; talk and hear. Specific vision abilities include close vision 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