Clinical Research Coordinator II
Job Location:
Peoria, IL - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 subjects 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 subjects 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 institutional review board documents
Integrates proposed clinical trial with current research activities
Attends and participates in investigator meetings
Confirms 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 )
Find it here.
Discover the job the career the purpose you were meant for. At Carle Health were committed to fostering a workplace where every team member feels valued respected and empowered where passion and purpose come together to positively impact the lives of our patients and our communities. Find it all at Carle Health.
Our nearly 17000 team members and providers work together to support patient care across central and southeastern Illinois. Weve grown to include eight award-winning hospitals and a multispecialty provider group with more than 1500 doctors and advanced practice providers. Were developing the next generation of providers and healthcare professionals through Carle Illinois College of Medicine the worlds first engineering-based medical school and Methodist College. Carle BroMenn Medical Center Carle Foundation Hospital Carle Health Methodist Hospital Carle Health Proctor Hospital Carle Health Pekin Hospital and Carle Hoopeston Regional Health Center hold Magnet designations the nations highest honor for nursing care. We offer opportunities in several communities throughout central Illinois with potential for growth and life-long careers at Carle Health.
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 employees Form I-9 to confirm work authorization. For more information:
Carle Health offers a comprehensive benefits package for team members and providers. To learn more visit
Required Experience:
IC
