The Clinical Investigations Support Office provides support to the investigators in conducting cancer related clinical trials at the USC Norris Comprehensive Cancer Center. This person will be responsible for managing clinical data on complex Phase I therapeutic clinical trials.
This position is designed for someone with previous clinical data management experience who is able to work efficiently with minimal supervision, has problem solving capabilities, and is able to contribute effectively to the team. It is therefore important that this person demonstrate initiative and communicate well, verbally and in written communications. This person will be responsible for data management of assigned studies as well as assisting Study Coordinators in various duties and will assist CISO supervisors in orientation, training and mentoring of newly hired Clinical Research Data Specialists I and II.
This person relates primarily to the Study Coordinator with whom she/he works as a team and interacts with physicians, and other CISO staff. The Clinical Research Data Specialist Lead is accountable to the Medical Directors, the Associate and Assistant Directors of CISO and to the clinical program physician Investigators with whom he/she works.Â This person is familiar with and adheres to the policies and procedures of the hospital where working. The CISO Clinical Research Data Specialist Lead functions may include but are not restricted to those listed below.
I. Study Specific:
1. Able to practically apply strong knowledge of the federal regulations governing the protection of human subjects e.g. FDA, GCP/ICH guidelines, OHRP and HIPAA regulations.
i.Â Â Â Â Â Independently manages clinical data for assigned protocols
ii.Â Â Â Â Able to independently search for and locate required clinical data from various sources.
iii.Â Â Â Able to interpret protocol requirements for dose modification and various assessments.
iv.Â Â Â Ensures adherence to protocol by reviewing in real time source documents, worksheets and study data to identify any missing documentation and potential protocol violations.
v.Â Â Â Â Works with the QA Team to resolve missing/needed documentation in real time.
vi.Â Â Â Assists Clinical Research Data Specialist I and II with data entry as needed.
vii.Â Â Assists Study Coordinator in the task of obtaining treatment records from hospital or physician and/or outside laboratory results if patient was seen at an outside facility;Â if delegates to Data Specialist I and II, will oversee process.
viii.Â With Study Coordinator, ensures protocol required Pharmacokinetics/Pharmodynamic/Research samples are obtained, processed and transported per protocol
2.Â Â Â Â Attends and actively participates in all internal and external protocol start up orientations
i.Â Â Â Â Â Completes required protocol specific training,
ii.Â Â Â Â Is familiar with own assigned new clinical trials.
iii.Â Â Â Becomes familiar with all protocols assigned to the CISO CRAâs Team to be able to assist Study Coordinators and Data Specialist I and II with protocols.
3.Â Â Â Â Acts as the primary site contact for the sponsorâs CRA for assigned industry trials
i.Â Â Â Â Â Follows CISO SOP in coordinating with various units, such as Pharmacy and Regulatory and with the PI to ensure professional monitoring and auditing for the Sponsorâs visits.
ii.Â Â Â Â Provides Sponsorâs CRA with Patient Research Charts and ensures access to hard copies and electronic medical records during monitoring and auditing visits
iii.Â Â Â Responds to internal and external emails and data queries in a timely and professional manner.
iv.Â Â Â In a timely fashion, resolves and/or assists Study Coordinator in resolving issues identified in the Sponsorâs follow up letter after a monitoring visit.Â
v.Â Â Â Â When required, works with Regulatory Manager and CISO QA Team to ensure all issues identified in the Sponsorâs follow up letter are resolved.
4.Â Â Â Â Able to practically apply knowledge in research regulations, including the reporting of Serious Adverse Events (SAE) and protocol violations
i.Â Â Â Â Â When notified by Coordinator, promptly and accurately reports SAEs to various agencies, following protocol guidelines.
ii.Â Â Â Â When necessary, assists Data Specialist I and if requested, Data Specialist II in reporting SAEs per protocol.
iii.Â Â Â Recognizes Protocol Violations and promptly reports such violations to Coordinator
iv.Â Â Â Assists Data Specialist I, II in determining/assessing violations.
5.Â Â Â Â Ensures that collection of clinical data is available to the PI, Sponsor and CRO in a timely manner
i.Â Â Â Â Â Ensures proper completion of protocol required Clinical Research Forms (CRFs) in real time according to contract obligations.
ii.Â Â Â Â Effectively communicates with the Study Coordinator and CISO QA Team to resolve any clinical data issues in a timely manner on assigned studies as well as on studies assigned to the CISO CRAâs team.
iii.Â Â Â Reports to USC CRO on a regular basis via spreadsheets when study timepoints are reached so that Industry sponsor can be invoiced.
6.Â Â Â For in house, NCI sponsored and Cooperative Group studies, interacts with QA Team to ensure accuracy of CRFs prior to submission.
8.Â Â Â Â Participates in QAMC audits by thoroughly reviewing assigned patient chart and reporting on results.
9.Â Â Â Â Independently prepares for and participates in NCI, FDA, pharmaceutical and other audits for assigned trials, as well as any other trials assigned to the CISO CRAâs Team.
10.Â Â Has necessary experience and knowledge to assist Study Coordinator with patient work ups
i.Â Â Â Â Â Independently verifies subjectâs eligibility
ii.Â Â Â Â Sets up the Research Chart
iii.Â Â Â Schedules required screening tests and assessments.
11.Â Â Provides assistance and input to the PI for publishing study results when requested.
II.Â Â Â Â Â Staff orientation and training
1. When requested, assists with orienting, training and mentoring newly hired Data Specialists I.
2. Provides assistance and guidance to Data Specialists I and II in identifying and assessing protocol violations.
3. Provides assistance and guidance to Data Specialists I and II in completing protocol required SAE reports.
III.Â Â Â Â General
1. Follows CISO SOPs in conduct of work.
2. Knowledgeable about and complies with hospital regulations.
3. Follows Medical Records rules for using and returning charts and accessing EPF(Norris) and Affinity (LAC).
4. Attends and participates in required internal and external meetings and conference calls with sponsors
5. Ensures work environment is organized to function efficiently
6. Observes office etiquette, by acting courteously and professionally with fellow staff members.
7. Reports off to assigned Data Specialists and Study Coordinator when away from office for reporting SAEs and other duties for coverage.
Bachelorâs Degree or higher in Life Sciences or health related field or equivalent work experience is preferred; combined experience/education as a substitute
National professional clinical research certification e.g. SoCRA, ACRP is preferred.
Minimum 2 years of work experience in data management of clinical trials in an academic setting is required; 3 years experience preferred.
Broad knowledge of overall clinical trial processes
Ability to work independently with minimal supervision
Team player; able to work as part of the team to identify and resolve problems
Attention to detail; able to transcribe data with minimal errors
Excellent knowledge and understanding of medical terms and proficiency with various medical assessment criteria (i.e. RECIST, CTCAE)
Excellent verbal and written communication and time management skills
Completes Human Subject Training, HIPPA, GCP and Sexual Harassment on-line courses.
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum educationMinimum Experience: 2 yearsMinimum Field of Expertise: Experience in clinical trials data management. Requires strong attention to detail with prior data entry experience. Understands medical terms and familiar with various assessment criteria. Strong verbal and written communication skills. Able to manage time efficiently.
Internal Number: REQ20085750
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