Senior Clinical Research Coordinator
The CCTS Senior Clinical Research Coordinator is responsible for managing, coordinating and implementing all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting. Responsible for the implementation and conducting of multiple, complex research projects in the Clinical Research Center. Manages comprehensive patient protocol treatment schedules to maintain compliance to study protocol requirements. Develops and implements effective patient recruitment strategies. Oversees all aspects of various multi-faceted investigations. Prepares IRB submissions, regulatory document preparation
- Assist in establishing and coordinating the implementation of clinical research protocol priorities and organization structure.
- Train staff on research protocols and procedures.
- Extract data from complex medical records with expert accuracy.
- Notify and inform PI, physicians, clinical staff, affiliates and grant sponsors of adverse events and protocol modifications, including their impact on the clinical research program.
- Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the UIC Institutional Review Board (IRB), Protocol Review Committee and grant sponsors.
- Review laboratory and clinical procedures and evaluations regularly to ensure protocol compliance.
- Act as liaison between physicians, clinical staff and the UIC IRB office, grant sponsors and regulatory agencies to ensure priorities are clearly communicated and resources are allocated appropriately across multiple ongoing projects.
- Communicate clinical information and work with stakeholders to create best practice tools.
Client Enrollment and Protocol Compliance
- Assist PI, physicians and clinical staff in identification, recruitment and enrollment strategies of patients to increase enrollment and to meet clinical research protocols.
- Schedule and conduct clinical research visits required by the protocol and track participant visits.
- Schedule all patient examinations, repeat examinations, treatments and laboratory visits required by the protocol.
- Coordinate outreach to and liaison with staff at schools, community clinics, science fairs, etc. to make research presentations and recruit new clients for various research projects.
- Screen patients for protocol eligibility and participation in clinical research.
- Complete patient assessment of anthropometrics and perform phlebotomy.
- Execute informed consent process and monitor patient status; Enroll clients into programs, explaining the research protocols to the clients and parents, and obtain appropriate consent forms.
- Ensure that client enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and grant sponsor guidelines.
- Conduct clinical, behavioral and observational surveys of clients and parents.
- Collect and review client evaluations/assessments, surveys, and participant interviews to develop reports for the PI and appropriate agencies and grant sponsors.
- Complete accurate, concise, and legible documentation of all participant records and other source documentation and forms per protocol, (i.e. maintain drug documentation, reconciling study drug accountability).
- Conduct basic lab duties including centrifuging, alloquoting, and storing and shipping of study specimens.
- Prepare study data for grant progress reports, analysis for meeting presentations, and publications.
- Participate in required clinical research education and training programs.
- Perform other related duties and participate in special projects as assigned.
Ideal candidates would have the following qualifications:
- A minimum of a Bachelor’s degree in nursing, mental health, psychology, pharmaceutical sciences, social science, or a related field required. Master’s degree is preferred.
- Certified Clinical Research Coordinator (CCRC) preferred.
- Current Illinois licensure as a Registered Professional Nurse preferred.
- A minimum of 5 years of experience in a research discipline required.
- Experience in a clinical research setting, experience working with Federal Regulations and IRB’s.
- Prior experience with medical terminology and procedures.
- Ability to manage multiple tasks.
- Strong interpersonal and customer service skills. Requires excellent communication, organization, presentation and computer/pc skills.
Posting Closes February 1, 2022
Senior Regulatory Specialist
The CCTS Senior Clinical Research Coordinator is responsible for developing and managing various clinical study protocols related to clinical and translational research and oversees related regulatory requirements to ensure compliance. Responsibilities also include senior level mentoring and training of clinical research teams and ongoing development, assistance with the development of standard operating procedures and advance knowledge of specialized regulatory topics.
- Collaborate with Principal Investigator and researchers to develop and implement research protocols in the CCTS. This includes creating participant consent forms, advertising materials, contact sheets, etc.
- Prepare study documents for submission to the IRB, sponsor or other regulatory authority and correspond with them as needed. Create and review documentation for institutional approval of: protocols, physicians, and clinical staff to open and/or continue participation in clinical research protocols from national clinical trials, industry, external agencies, and internal sources.
- Review IRB approved documents to ensure accuracy before protocols are implemented.
- Maintain accurate, complete and current information in appropriate format and databases to track clinical research compliance with FDA, NCI, UIC and sponsored guidelines, i.e. complete and process appropriate documentation as outlined by FDA, NCI, study sponsors and the university. Prepare and maintain regulatory binders for each clinical trial.
- Prepare responses to IRB and sponsor questions.
- Monitor progress of clinical research study developments on an ongoing basis. Propose and implement changes as needed.
- Serve as subject matter expert on regulatory related issues. Provide regulatory guidance, direction and support to all members of research team.
- Keep current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.
- Work with Clinical Research Coordinators and Research Specialists as needed to ensure understanding of study protocols.
- Guide, train, and advise other staff members and students on techniques, methods, and procedures.
- Mentor staff and coordinate staff trainings and ongoing professional development.
- Assist in the development of SOPs, policies and guidance documents for the CCTS.
- Keep abreast of and serve as the point of contact for specialized regulatory topics including, but not limited to, single IRB review, CTEP registration, single patient INDs, and ClincialTrials.gov registration and updates.
Ideal candidates would have the following qualifications:
- Bachelors degree in health or social science field required.
- Minimum of five years of related research experience; in regulatory compliance required. Minimum 3 years clinical research regulatory experience required.
- Knowledge of and experience working with Federal Regulations and IRBs required.
- Certification in one of the following: SoCRA, ACRP, PRIM&R preferred and required within 2 years of hire.
- Strong communication skills; ability to communicate clearly and concisely both in written and verbal communication.
Posting Closes February 3, 2022
The Research Specialist collaborates with PIs and Program leadership in the development of translational research projects, professional development and mentoring research objectives and proposals to advance investigator research efforts in clinical and translational science. The position supports the implementation and evaluation of CTSA-grant funded team science and workforce development initiatives. The position works with both programs in the implementation and evaluation of University, citywide and nation-wide initiatives in support of the CTSA priorities for developing and supporting team science, as well as a diverse clinical and translational workforce to address clinical, translational and public health issues.
- Collaborate with Principle Investigator and leadership to develop objectives, implement protocols and evaluate outcomes.
- Oversee daily management of CCTS workforce development and team science initiatives, proposing and implementing changes as needed.
- Represent CCTS within the CTSA Network through the development and exchange of best practices and collaborative initiatives.
- Contribute material, prepare results and assist in the writing of research findings for publications, papers, presentations, grants, and other documents for publication. Assist principal investigator in grant and manuscript submission.
- Bachelor’s degree in social science or related field required. Master’s degree in social science preferred.
- A minimum of 3 years related research experience.
- Possesses and applies comprehensive knowledge of research principles, concepts, practices and methods.
- Project management and/or grant management experience strongly preferred.
- Strong communication, organization and interpersonal skills required.
- Ability to work well independently and within a team environment.
Posting Closes February 7, 2022
The University of Illinois at Chicago is an affirmative action, equal opportunity employer that has a strong institutional commitment to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. We are committed to equal employment opportunities regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
University of Illinois faculty, staff and students are required to be fully vaccinated against COVID-19. If you are not able to receive the vaccine for medical or religious reasons, you may seek approval for an exemption in accordance with applicable University processes.
The University of Illinois may conduct background checks on all job candidates upon acceptance of a contingent offer. Background checks will be performed in compliance with the Fair Credit Reporting Act.
The University of Illinois System requires candidates selected for hire to disclose any documented finding of sexual misconduct or sexual harassment and to authorize inquiries to current and former employers regarding findings of sexual misconduct or sexual harassment. For more information, visit https://www.hr.uillinois.edu/cms/One.aspx?portalId=4292&pageId=1411899