UnityPoint Health Clinical Research Associate in Peoria, Illinois
UnityPoint Health - Methodist | Proctor | The Point of Unity is You.
UnityPoint Health is one of the nation's most integrated health systems. We have a vision for healthcare, and it starts with you: "Best outcome for every patient, every time."
Through relationships with more than 280 physician clinics, 29 hospitals in metropolitan and rural communities, and home care services throughout its 8 regions, UnityPoint Health provides care throughout Illinois and Iowa.
We surround you with care that is coordinated between your doctor's office, hospital and in your home.
With almost 600 board-certified physicians backed by a dedicated team of healthcare professionals who combine high-tech medicine with genuine warmth and caring, UnityPoint Health - Methodist provides coordinated clinic, hospital and home-based care for patients in Central Illinois.
Clinical Research Associate
UnityPoint Health-Methodist Campus
Shift: Full-time / 40 hrs per week 8A-5P
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.
PARTICIPATES IN PROTOCOL ASSESSMENT/PLANNING BY:
Listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations, and study procedures
Preparing and submitting regulatory documents to sponsor (e.g. Form FDA 1572, laboratory certification and normal values, curriculum vitae etc.)
Preparing and submitting institutional review board documents
Integrating proposed clinical trial with current research activities
Confirming that contact, , IRB approval of protocol and informed consent have been received prior to study initiation
Completes Sponsored protocol training including (GCP, EDC, IVRS, IRB, …)
PARTICIPATES IN SUBJECT RECRUITMENT, ENROLLMENT, AND FOLLOW-UP PROCEDURES BY:
Maintaining patient screening/enrollment logs
Follows patient population clinically and maintains documentation supporting study o Reviewing inclusion/exclusion criteria with investigator to assure subject eligibility
Reviewing and verifying required source documents in subject's medical record to confirm study eligibility
Assuring that all screening, eligibility, and enrollment procedures are performed
Reviewing the protocol, informed consent form, and follow-up procedures with potential study subjects
Conducting interviews to assess the subject's ability and willingness to follow and complete study procedures and visits
Obtaining informed consent from research subjects prior to any study-related procedures and documenting appropriately
Following randomization procedures as per protocol
Assures administration of study article as appropriate
Scheduling subjects for follow-up visits o Reviewing diaries and questionnaires completed by subject
Ensuring appropriate specimen collection, batching and shipping as required
Assessing subject compliance with the test article and follow-up visits
Recognizing and reporting common laboratory values and alerts to investigator and sponsor
Protecting patient privacy during initial and follow-up interviews
Securing safe storage of study-related documents o Assuring appropriate disposal of sensitive documents
DOCUMENTS AND MAINTAINS ALL STUDY-RELATED PROCEDURES, PROCESSES, AND EVENTS BY:
Planning and design of new forms/source document tools to be used in protocol implementation
Documenting protocol deviations and exemptions o Obtaining and reviewing original source documents (e.g., recordings, scans, tests, procedure results) as needed
Abstracting data from medical records, clinic, consultation, and referral notes to study forms and flowsheets
Recording accurate and timely data onto case report forms
Maintaining source documentation for all case report entries, as applicable
Keying data for electronic submission o Transmitting data via fax, mail or electronically as requested
Correcting and editing case report form entries as appropriate o Resolving data queries
Completing and maintaining the study article dispensing log
Maintaining files of all study-related documentation
Preparing case report forms for sponsor/audit review o Collecting source documents for sponsor/audit review
COMMUNICATES EFFECTIVELY WITH SUBJECTS, RESEARCH TEAM, IRB, AND SPONSOR BY:
Maintaining a list of sponsor/CRO contacts for each protocol
Providing subjects with information about reporting study-related events to research team
Establishing a mechanism to contact subjects for follow-up visits, new information, etc.
Utilizing a phone log to document telephone communications
Contacting primary care providers to discuss/inform of patient enrollment and study progress
Meeting regularly with investigator and research team to discuss subject participation and protocol progress
Submitting protocol amendments and progress reports to IRB in required timeframes
Timely notification of the investigator, sponsor, and IRB of adverse events as outlined in the protocol
Scheduling sponsor monitoring visit.
Meeting with monitors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues.
• Certificate program in the field of medical office assistance or Licensed Practical Nurse in the State of Illinois
• 1-3 years experience in/with clinical experience in a physician office, computer knowledge, and detail oriented preferred
• 1-3 years of experience successfully working with a wide variety of people required.
License and Certification:
• Valid CPR required before start date
• Valid Driver’s License in the state of IL
Required English Skills:
Advanced reading skills
Advanced writing skills
Advanced oral skills
Ability to respond appropriately to customer/co-worker o Interaction with a wide variety of people
Maintain confidential information o Ability to communicate only the facts to recipients or to decline to reveal information
Ability to project a professional, friendly, helpful demeanor
Intermediate computer knowledge
Ability to troubleshoot minor problems within a Windows OS, operates within a network environment, uses spreadsheet, database, word processing and internet applications proficiently.
Learns new applications without difficulty and is able to aid others in immediate work area with computer questions.
Requisition ID: 2018-43164
Street: 221 NE Glen Oak Ave
Name: 5020 UnityPoint Health Methodist Medical Center
Name: Research Administation Office
FTE (Numeric Only; Ex. 0.01): 1.0
FLSA Status: Non-Exempt
External Company URL: http://www.unitypoint.org