The Clinical Research Coordinator I (CRC I) assists the applicable research operations leadership, supervisors or Site Directors, and Investigators in the management of patients enrolled in clinical trials. He/she collects and reports data appropriately that includes but is not limited to; audit preparation and investigational product tracking. In addition, the CRC I, in conjunction with Physician Investigators and colleagues must assist in the development and execution of recruitment plans to meet patient accrual targets for each clinical trial. As a CRC I he/she will enlist support for specific tasks from various clinical and project team members and ancillary service providers to assure the meeting of trial objectives within budget and schedule.
Duties and Responsibilities:
- Identification, screening, randomization and enrollment of patients in IRB approved clinical trial protocols.
- Complete all trial related procedures, including clinic visits, etc., according to each individual IRB approved clinical trial protocol, established Standard Operating Procedures (SOP’s), Sponsor specifications and Good Clinical Practice (GCP), while following all HIPAA and OSHA guidelines. This includes direct patient care activities; such as informed consent, physical assessments, blood draws, medication administration, ECG, Fibroscans, etc.
- Ensure paper paper or electronic source data is attributable, legible, contemporaneous, original, and accurate (ALCOAC).
- Building and maintaining excellent communication with all delegated Investigators and others needed to conduct quality research to foster an excellent reputation of site research.
- Ensure efficient monitoring of all trials by ensuring all subject charts are maintained accordingly that the data is clean and entered accurately into the sponsor EDC in timely fashion.
- Ensure all patient charts are reviewed by CRC II as needed. All charts reviewed by CRC II prior to first Site Monitoring Visit with study sponsor.
- Assist CRC II with site initiation activities, including creating and submitting Regulatory and site-specific documents, engaged during site start-up, interim submissions as required by Sponsor, through study closure.
- Assist CRC II with scheduling routine regulatory review of IRB documents and compliance/quality control checks of subject charts for each assigned research study.
- Assist CRC II with creating and maintaining up to date Source Documents for each study and conduct strategic planning as needed.
- Review audit findings from monitor and/or internal auditor and discuss with CRC II and/or Executive Site Director when needed.
- Attend all clinical operations and staff meetings
- Attend Investigator meetings and training sessions as in the absence of lead CRC. Preferred, but not required.
- Additional duties as assigned.
- High School Diploma or Equivalent. MA/BS in related field preferred.
- Experience in clinical research or 3-5 years in a medical ancillary position.
- Preferred but not required experience with completing entire protocol guided visits and procedures in clinic, knowledge of the process of reporting Adverse events and Serious Adverse events, skills in preparing for site monitoring visits, Electronic Data Capture (EDC) experience, Managing Regulatory data for assigned studies, and EMR based recruitment to identify protocol eligible patients
- Strong Interpersonal skills, organizational strengths, detail-oriented and an ability to interact well with others in a collaborative setting. Must display ability to work independently.
- Employee evaluations will be conducted by the Executive Site Director annually. Performance evaluations completed by CRC II after 30 and 90 days and more frequently if deemed necessary. Valid U.S. Driver’s License
Working Conditions and Physical Requirements:
- Performs tasks which involve exposure to blood, body fluid, or tissue. Must be able to stand, walk and move about freely. May be required to squat, bend, kneel, lift up to 30 pounds and reach overhead on occasion.