The Clinical Research Coordinator works under the general direction of the LRIC/Recruitment Navigator in partnership with the ITM, Principal Investigators (PIs), Co-Investigator(s) and other study personnel.The Clinical Research Coordinator works with the LRIC Coordinator works under the general direction of the Clinical Research Center Director in partnership with Clinical Research Center Principal Investment Manager, Clinical Research Manager, department, ITM institutions and the OCR to support and provide guidance on the administration of the compliance, financial, and other related aspects of the ITM. The Clinical Research Coordinator coordinates recruitment, Design Studios, clinical trial activities and performs a variety of duties involved in the Trial Recruitment Innovation office (TRIO). The Clinical Research Coordinator plays a critical role in ensuring recruitment and innovation with studies within the 6 ITM institutions, Federal guidelines, local guidelines and in accordance with Good Clinical Practice (GCP).
This at-will position is wholly or partially funded by extramural funds (e.g., grant, gift, endowment) which is renewed under provisions set by the grantor. Employment will be contingent upon the continued receipt of these extramural funds and satisfactory job performance. If this position is eliminated due to the discontinuation of extramural funding, you will be given a minimum of one pay period's written notice (if exempt: 30 days, if non-exempt: 2 weeks), or pay in-lieu of notice.
Assists the study team with all aspects of conducting clinical trials from startup to closeout for studies at all 6 ITM institutions.
Responsibilities include, but are not limited to, enrollment of subject in research study and ensuring protocol adherence.
Reviews the protocol plan to understand and assist with feasibility evaluation and planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.
Monitors recruitment and identifies studies at risk for not meeting timelines and milestones.
Organizes and actively participates in institutional site visits at the 6 different ITM institutions.
Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified timeâpoints; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.
Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study, PI, and regulatory agency specifications.
Maintains accurate and complete records which may include, but are not limited to, Institutional Review Board (IRB) communication, source documentation, CRFs, and study related communication.
May prepare and maintain protocol submissions and revisions.
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required.
Ability to communicate with tact and diplomacy required.
Strong organizational skills required.
Strong communication skills (verbal and written) required.
Excellent interpersonal skills required.
Strong data management skills and attention to detail required.
Knowledge of Microsoft Word, Excel and Adobe Acrobat required.
Ability to read and understand complex documents (e.g., clinical trials) required.
Ability to handle competing demands with diplomacy and enthusiasm required.
Ability to absorb large amounts of information quickly required.
Adaptability to changing working situations and work assignments required.
Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines preferred.Knowledge of medical terminology / environment preferred.
Understanding of the IRB submission and review process and when and how to apply for IRB review preferred.
Understanding of the federal research regulations and the ability to identify the federal research organizationsâ™ role in regulating human research participation preferred.
Education, Experience or Certifications:
Bachelors degree required
Minimum 1 year of research experience
Working Conditions and Physical Requirements:
Direct contact with potential research participants
Cover Letter preferred
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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Internal Number: JR03918
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