Clinical Research Coordinator
Company: Carle Health
Location: Peoria
Posted on: May 2, 2024
Job Description:
Position Summary:
Promotes good clinical practices in the conduct of clinical
investigations by possessing an in-depth knowledge of federal
regulations and guidance documents for the conduct of clinical
trials and human subject protection, assuring compliance with
protocol and regulatory requirements, and by collecting, recording,
and maintaining data and source documentation. This role reviews
technical operations ensuring that all processes, protocols &
procedures are quality controlled & functioning up to standards.
This role ensures that all study activities are completed by
strictly following Good Clinical Practices (GCP) & all current
local, state, & federal laws, regulations, guidance, policy &
procedure developed by the applicable Institutional Review Boards
(IRB's), Food & Drug Administration (FDA) Code of Federal
Regulations (CFR), & the International Conference on Harmonization
(ICH).
Qualifications:
EDUCATIONAL REQUIREMENTS
Bachelor's Degree in Related Field or H.S. Diploma/GED in with 3+
years* experience in/with clinical setting or research
background
Essential Functions:
- DOCUMENTS AND MAINTAINS ALL STUDY-RELATED PROCEDURES,
PROCESSES, AND EVENTS BY: Coordinates assigned Research Studies at
all levels of acuity within the scope of Licensure. Plans and
designs new forms/source document tools to be used in protocol
implementation Documents protocol deviations and exemptions Obtains
and reviews original source documents (e.g., recordings, scans,
tests, procedure results) as needed Abstracts data from medical
records, clinic, consultation, and referral notes to study forms
and flowsheets Records accurate and timely data onto case report
forms Maintains source documentation for all case report entries,
as applicable Keys data for electronic submission Transmits data
via fax, mail or electronically as requested Corrects and edits
case report form entries as appropriate Resolves data queries
Completes and maintains the study article dispensing log Maintains
files of all study-related documentation Prepares case report forms
for sponsor/audit review Collects source documents for
sponsor/audit review
- PARTICIPATES IN SUBJECT RECRUITMENT, ENROLLMENT, AND FOLLOW-UP
PROCEDURES BY: Monitors enrollment goals and modifying recruitment
plan as necessary Maintains patient screening/enrollment logs
Follows patient population clinically and maintains documentation
supporting study Reviews inclusion/exclusion criteria with
investigator to assure subject eligibility Reviews and verifies
required source documents in subject's medical record to confirm
study eligibility Assures that all screening, eligibility, and
enrollment procedures are performed Reviews the protocol, informed
consent form, and follow-up procedures with potential study
subjects Conducts interviews to assess the subject's ability and
willingness to follow and complete study procedures and visits
Obtains informed consent from research subjects prior to any
study-related procedures and documenting appropriately Follows
randomization procedures as per protocol Assures administration of
study article as appropriate Schedules subjects for follow-up
visits Reviews diaries and questionnaires completed by subject
Ensures appropriate specimen collection, batching and shipping as
required Assesses subject compliance with the test article and
follow-up visits Recognizes and reporting common laboratory values
and alerts to investigator and sponsor Protects patient privacy
during initial and follow-up interviews Secures safe storage of
study-related documents Assures appropriate disposal of sensitive
documents
- COMMUNICATES EFFECTIVELY WITH SUBJECTS, RESEARCH TEAM, IRB, AND
SPONSOR BY: Maintains a list of sponsor/CRO contacts for each
protocol Educate patients on how to use medication or device in
study. Provide management feedback on how to integrate research
operations in clinics for most effective workflow. Provides
subjects with information about reporting study-related events to
research team Establishes a mechanism to contact subjects for
follow-up visits, new information, etc. Utilizes a phone log to
document telephone communications Contacts primary care providers
to discuss/inform of patient enrollment and study progress Meets
regularly with investigator and research team to discuss subject
participation and protocol progress Submits protocol amendments and
progress reports to IRB in required timeframes Completes timely
notification of the investigator, sponsor, and IRB of adverse
events as outlined in the protocol Schedules sponsor monitoring
visit. Meets with monitors during routine visits to discuss case
report form completion, query resolution, and other
protocol-related issues.
- PARTICIPATES IN PROTOCOL ASSESSMENT/PLANNING BY: Lists and
clarifies questions and concerns with the investigator and sponsor
regarding enrollment goals, sponsor expectations, and study
procedures Prepares and submits regulatory documents to sponsor
(e.g. Form FDA 1572, laboratory certification and normal values,
curriculum vitae etc.) Prepares and submits i
We are an Equal Opportunity Employer and do not discriminate
against any employee or applicant for employment because of race,
color, sex, age, national origin, religion, sexual orientation,
gender identity, status as a veteran, and basis of disability or
any other federal, state or local protected class. Carle Health
participates in E-Verify and may provide the Social Security
Administration and, if necessary, the Department of Homeland
Security with information from each new employee's Form I-9 to
confirm work authorization. - For more information:
human.resources@carle.com.
Effective September 20, 2021, the COVID 19 vaccine is required for
all new Carle Health team members. Requests for medical or
religious exemption will be permitted.
Keywords: Carle Health, Davenport , Clinical Research Coordinator, Healthcare , Peoria, Iowa
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