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
Certifications: Certified Clinical Research Coordinator (CCRC) within 2.5 years - Association of Clinical Research Professionals (ACRP), Education: H.S. Diploma/GED; Bachelor's Degree: Related Field, Work Experience:
Responsibilities
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 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, …)
About Us
Find it here.
Discover the job, the career, the purpose you were meant for. The supportive and inclusive team where you can thrive. The place where growth meets balance – and opportunities meet flexibility. Find it all at Carle Health.
Based in Urbana, IL, Carle Health is a healthcare system with nearly 16,600 team members in its eight hospitals, physician groups and a variety of healthcare businesses. 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 nation’s highest honor for nursing care. The system includes Methodist College and Carle Illinois College of Medicine, the world’s first engineering-based medical school, and Health Alliance™. 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 employee's Form I-9 to confirm work authorization. | For more information: human.resources@carle.com.
Compensation and Benefits
The compensation range for this position is $23.58per hour - $39.38per hour. This represents a good faith minimum and maximum range for the role at the time of posting by Carle Health. The actual compensation offered a candidate will be dependent on a variety of factors including, but not limited to, the candidate’s experience, qualifications, location, training, licenses, shifts worked and compensation model. Carle Health offers a comprehensive benefits package for team members and providers. To learn more visit careers.carlehealth.org/benefits.