Aspen Dental Clinical Research Coordinator in Rochester (Winton & Blossom), New York
WellNow Urgent Care℠ is here to help our patients get well. Founded in 2011 with just 12 locations, we have quickly grown to 92+ locations across New York, Illinois, Ohio and Michigan. Our growth-focused model positions us as one of the fastest-growing providers of quality urgent, virtual, and occupational care. Come join our team today! Our continued growth has created an opportunity to join our team as a Clinical Research Coordinator.
The Clinical Research Coordinator will be responsible for working on studies and completes varied tasks critical to the management of clinical research studies. The primary responsibility of the Clinical Research Coordinator is the protection of human subjects. They will learn all basic clinical research study activities and apply all federal and other regulatory guidelines having impact on those studies. The Clinical Research Coordinator will have an understanding of ICH/GCP guidelines for human research and the Code of Federal Regulations for Human Subjects.
Coordinate and manage the clinical research studies to promote compliance with study protocols and ensure the safety and welfare of all patients/study participants.
Ensure that each clinical research study is conducted accurately and in compliance with ICH/FDA regulations and guidelines
Recruit and screen potential patient/study participants with each clinical research study protocol’s inclusion and exclusion criteria and adhering to safety and compliance issues.
Obtain proper written informed consent from each potential study participant, prior to participation in the study.
Coordinate and manage patient/study participant visits with each clinical research study. Tasks required to fulfill this responsibility include, but are not limited to, scheduling subject visits and reminding subjects of upcoming visits, reacting to and reporting new/unanticipated adverse events; performing electrocardiograms, taking and interpreting vital signs; properly identifying and obtaining relevant laboratory specimens, receiving the results of laboratory tests associated therewith, and recording those tests; shipment of specimens and drug; and coordinating and assisting with physical examinations.
Collect accurate and complete data for each clinical research study, including preparation and review of source documents and case report forms.
Ensure required documentation, including source documents and case report forms, has been accurately and successfully completed and appropriately filed and uploaded to the Sponsor and/or CRO.
Communicate with pharmaceutical company Sponsors and monitors concerning all aspects of study activities.
Coordinate and manage Sponsor audits, Sponsor site visits and Sponsor monitoring visits. Meet and discuss with monitors and other representatives the progress and results of clinical research studies.
Work with Sponsor for accurate and timely study close-out, including completion of all documents and return to Sponsor of requested study supplies and equipment. Accurately prepare study documents for archiving, including local storage of the files followed by off-site storage as appropriate.
Travel and attend meetings and activities associated with clinical research studies, including, but not limited to, investigator meetings, to acquire additional specialized knowledge in the area pertaining to a clinical research study.
Maintain confidentiality with all patient information (HIPAA)
Successful completion of FAA training concerning the handling and shipping of hazardous goods and materials, followed by recertification every two years following initial certification.
Successful completion of GCP course, such as Collaborative Institutional Training Initiative (CITI) training course on clinical research, followed by recertification as required following initial certification.
Certified Medical Assistant
2 years’ full-time clinical research experience
Ability to function independently without close supervision, and to consistently exercise discretion and the highest level of good clinical and other professional judgment.
Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine.
Ability to effectively devote keen and acute attention to detail.
Ability to multi-task and perform multiple critical tasks simultaneously
Strong written and verbal communication skills
Strong interpersonal skills
Strong self-motivation skills and the ability to be a “self-starter”
Ability to work as a team and independently as needed, while simultaneously managing a variety of clinical research study related projects.
Significant travel required – 100%.
WellNow is an EOE
Street: Blossom Rd.
Travel: Up to 25%
External Company URL: https://wellnow.com/