Clinical Research Coordinator II

Clinical Research Coordinator II

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).

• 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)