Clinical Research Coordinator 2
Hyde Park Campus
About the Unit
The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research.
- The Clinical Research Coordinator 2 (CRC2) 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 director/manager and/or the Office of Clinical Research (OCR).
- The CRC2 independently manages, facilitates and monitors the daily activities of multiple moderately complex protocols and performs a variety of duties involved in the collection, compilation, documentation and reporting of data.
- This position entails all aspects of conducting clinical research: recruiting/interviewing, screening, consenting, enrollment, subject follow-up, completion of case report forms and adverse event reporting. The CRC2 will educate subjects and parents/guardians about study procedures to be performed. 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.
- 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, 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; monitors data for adverse events. 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 director and/or the Office Clinical Research.
- 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, 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.
- 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. Understands 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. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications. Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines required.
- Demonstrated 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.
- Ability to handle sensitive matters with tact and discretion required.
- Excellent interpersonal skills required.
- Strong data management skills and attention to detail required.
- Ability to participate in protocol review and clinical trials evaluations required.
- Knowledge of medical terminology / environment required.
- Ability to handle competing demands with diplomacy and enthusiasm required.
- Excellent time management and ability to prioritize work assignments required.
- Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required.
- Familiarity with Good Clinical Practices (GCP) required.
- Ability to read and understand clinical trials protocols required.
- 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 organizations' role in regulating human research participation preferred.
- Ability to absorb large amounts of information quickly required.
- Adaptability to changing working situations and work assignments required.
ADDITIONAL JOB DESCRIPTION:
Education, Experience, and Certifications:
- Bachelor's degree required
- 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.
Licenses and Certifications:
- Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials Management & Regulatory Compliance certification preferred.
Technical Knowledge or Skills:
- Experience submitting protocols to the IRB preferred.
- Familiarity with medical record system (Epic) and terminology preferred.
- Experience working on lymphoma-based clinical trials preferred.
- Experience working with the Children's Oncology Group preferred.
The following documents are required to be considered for this position:
- Resume / CV
- Cover Letter
- Reference List
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
Background Check Required?
Remove from Posting On or Before
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