Clinical Research Coordinator 2



Hyde Park Campus

Department
20137 Radiation Oncology

About the Unit

Job Information

Job Summary:

The Clinical Research Coordinator 2 (CRC2) reports to the Executive Administrator, is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel, and under the limited direction of departmental, clinical research manager and/or the Office of Clinical Research (OCR). With limited supervision and/or guidance, the CRC2 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the OCR to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study. The CRC2 independently manages, facilitates and monitors the daily activities of multiple moderately complex clinical trials and performs a variety of duties involved in the collection, compilation, documentation and reporting of clinical research data. The CRC2 plays an instrumental role in ensuring compliance with the study protocol, Federal guidelines, Local guidelines, and in accordance with Good Clinical Practice (GCP).

The CRC2 may assist with the training and/or mentoring of CRC1 or other CRC2 staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study.

Responsibilities:

Research Conduct/Study Management:
  • Manages all aspects of conducting clinical trials from startup to closeout for multiple concurrent moderately complex clinical trials that may include national level, multi-institutional pharmaceutical trials and multi-centered cooperative group and intergroup studies. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.
  • Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
  • Responsible for the oversight/monitoring of all clinical trial expenses; reviews the protocol plan to differentiate standard of care versus research to ensure that clinical care expenses, personnel effort, site initiation costs, IRB fees, pharmacy costs, equipment, and supplies are tracked and captured as direct costs to the clinical trial.
  • Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques
  • Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, noting severity and causality and attribution of the adverse events; reports findings to PI, sponsor and IRB under general direction of department, clinical research manager and/or the Office Clinical Research.
  • Organizes and actively participates in site visits from sponsors and other relevant study meetings.
  • Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.


Data Management:
  • Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. 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 time-points; 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 sponsor, PI, and regulatory agency specifications.


Regulatory Compliance:
  • Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
  • Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
  • Ensures compliance with federal regulations and institutional policies.
  • Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
  • Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
  • Ensures compliance with federal regulations and institutional policies.
  • May assist with preparation of protocols, amendments and other necessary documents for review by the IRB and sponsor.


Other duties as assigned.
  • May train and/or mentor CRC1 or other CRC2 staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study.
  • Other duties as assigned.


Additional Requirements

Education:
  • Bachelor's degree required.
  • Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials Management & Regulatory Compliance certification preferred.


Experience:
  • Minimum of 2 years of clinical research experience or relevant experience required.
  • Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials) required.


Required Documents:
  • CV
  • Cover letter

Note:When applying, all required documents MUST be uploaded under the Resume/CV section of the application

Benefit Eligibility
Yes

Pay Frequency
Monthly

Pay Range
Depends on Qualification

Scheduled Weekly Hours
40

Union
Non-Union

Job is Exempt?
Yes

Drug Test Required?
No

Does this position require incumbent to operate a vehicle on the job?
No

Health Screen Required?
No

Background Check Required?

Yes

Posting Date
2018-02-22-08:00

Remove from Posting On or Before
2018-08-22-07:00

Posting Statement:

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

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Full time
JR00534

About Us
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PI101322121

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