WHO WE ARE:

Since 2015, we have been on 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 TrialScout, the first ever patient rating 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 around 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. We are looking to expand our growing team!

WHAT WE OFFER:

 We are proud to offer competitive benefits, salary, and an environment focused on helping you grow personally and professionally.

WHAT YOU’LL DO: 

 The Research Coordinator 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

• Meeting metrics and goals related to each assigned study

• Obtaining appropriate certification of required trainings

WHO YOU ARE:

• 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 and like to dot i's and cross t's. 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 are a great communicator - both verbally and written. You will need to synthesize and articulate information to the Sponsor/CRO, team, and study participants.

• 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.

YOUR QUALIFICATIONS:

• Bachelor's degree required. Licensed as a registered nurse (RN) or licensed practical nurse (LPN) in the state of New York is strongly preferred.

YOUR PREFERRED EXPERIENCE:

• 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

• 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’LL REPORT TO:

Reporting to the Clinical Services Group Lead, you will be part of our amazing Clinical Operations group and work cross collaboratively with our Regulatory and Business Development groups.

THE OTHER FINE PRINT:

• LOCATION: This position is located in Buffalo, NY

• TRAVEL: May require regular travel to other research site locations within the Western New York territory

• 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 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