|Job Opening ID||16|
|Roles and Responsibilities||AccessMD is a fast growing Midwest-based company that also performs clinical research for the pharmaceutical and biotechnology industries. We have performed clinical research trials for the past 5 years for numerous therapeutic indications and work with an expanding list of Sponsors and CROs. We operate research from 7 urgent care centers in OH, with plans to expand into MI. The key to our success has been the ability to recruit from our network of 23 urgent care centers, along with detailed execution of the protocol with complete and accurate data and a strong focus on subject safety.|
Hometown Urgent Care is currently looking for an experienced Clinical Research Coordinator (CRC) to work on studies with our Columbus PIs, to assist with training the CRCs. The ability to travel by car to various sites is a must.
The CRC performs multiple and varied tasks critical to the management of clinical research studies. The primary responsibility of the CRC is the protection of human subjects. The CRC learns all basic clinical research study activities and learns and applies all federal and other regulatory matters having impact on those studies. The CRC 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 good clinical practice regulations and guidelines to ensure compliance with federal law.
· 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. To successfully satisfy this responsibility, the CRC must be wholly familiar with the protocols, procedures and criteria associated with each clinical research study and accurately interpret and apply those protocols, procedures and criteria.
· 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.
· Collection of accurate and complete data for each clinical research study, including preparation and review of source documents and case report forms. Ensuring that all 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. Successful and timely resolution of queries from Sponsor and/or CRO is also a responsibility.
· Effectively communicate with pharmaceutical company Sponsors, monitors and CROs concerning all aspects of study activities. Coordinate and manage Sponsor audits, Sponsor site visits and Sponsor monitoring visits. Successful completion of this responsibility requires the CRC to meet and discuss with monitors and other representatives the progress and results of clinical research studies.
· Utilize computer software applications such as Clinical Conductor and Sponsor software programs to enhance workflow and study activity efficiency. Input data and update fields in Clinical Conductor as appropriate for study financial accounting and study management.
· Work with Sponsor and/or CRO 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.
· Travel to and perform duties of the position at other Hometown locations when assigned or directed to do so.
|Skill Set||Experience/Training: |
2-5 years experience in study coordination
Phlebotomy and EKG experience;
Familiarity with GCP and FDA/ICH regulations;
Proficiency with Microsoft Office (Word, Excel, Outlook);
Must have excellent written, verbal and interpersonal skills, strong organization skills, and a strong attention to detail
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