- Company: Circuit Clinical
- Posted: 08/11/2021
- Location: Buffalo, NY
- Category: Administrative Legal
Who we are:
Since 2015, we have been 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 by creating our award-winning technology TrialJourney, the first ever patient ratings and review platform for clinical trials. Our technology isn’t the only award winner! As a winner of the 2020 Best Places to Work contest by the Buffalo Business First periodical, we work hard to make sure our culture is focused on transparency, accountability, performance, and continuous learning – because just as we are obsessed with the patient experience in clinical trials, we are equally obsessed with the employee experience.
What we offer:
We are proud to offer a competitive salary, benefits package, and an environment focused on helping you grow personally and professionally through continuous learning and mentoring.
What you’ll do:
As the Compliance Specialist, you will be responsible for the ongoing review of all documentation that supports the proper conduct of clinical trials for industry sponsors and/or sites in the network. These tasks aid in ensuring compliance and preparing for auditing activities. This position will work closely with the Clinical Operations and Clinical Quality Management Teams.
You’ll be responsible to:
- Review Source and Regulatory documentation to ensure compliance with clinical trial protocol, FDA regulations, GCP and Circuit SOP.
- Review, edit and draft SOPs as needed to support company processes and compliance.
- Assist with preparation and resolution of findings for external audits or inspections.
- Collaborate with the Clinical Operations Team to manage and resolve internal and external issues identified throughout a trial.
- Maintain databases of internal and external audit findings to identify and respond to trends.
- Attend network meetings, conference calls and monthly staff meetings as appropriate.
- Participate in the development of educational activities and programs as it pertains to compliance.
Who you are:
- First and foremost, you have integrity in all that you do. You take a professional approach to your work and don’t compromise your ethical standards.
- You are able to multitask without missing details or deadlines.
- Your attention to detail is among your finest qualities and don’t miss a beat despite the fast-paced environment.
- You are organized and approach your work systematically.
- You are a great communicator – both verbally and written and understand when to escalate issues.
- You are analytical and possess a problem solving attitude.
- You are able to grasp new concepts quickly and to assimilate data from a range of areas.
- You have strong, professional negotiation and arbitration skills.
- You are able to work well in a team environment and can take initiative when needed.
- You value what we value: Thoughtful transparency, Expansive Inclusion, Relentless Performance, Fearless Accountability, Talent Obsession, and Continuous Learning.
- Bachelor Degree AND two years in a compliance or quality related role, preferably in a healthcare, research or other science related field, OR an equivalent combination.
Your preferred experience:
- Proficiency with the English language
- Previous Clinical Research Associate/Monitoring experience a plus
- Knowledge of Institutional Review Board, Food Drug Administration and Good Clinical Practice guidelines required
- Knowledge of scientific and clinical research terminology
- Experience recognizing deviations in clinical assessments, normal and abnormal laboratory values, and clinical outcomes
- Demonstrated proficiency with electronic data capture systems, interactive web/voice response systems, and electronic medical record systems
- Demonstrated proficiency with Microsoft Office and G-Suite
Who you’ll report to:
- Reporting to our Director of Regulatory Affairs and Compliance, you will be part of our top not Regulatory Team and work closely with Clinical Operations and Clinical Quality Management.
The other fine print:
- Location: This position is located at our headquarters in Buffalo, NY with the option for remote work as needed
- Travel: Visits to clinical study site(s), which include hospitals and physician offices, may be required as needed. May require travel between multiple sites at various times.
- 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
- Occasionally lift and/or move up to 50 pounds.
- 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