Job Description

Description

JOB SUMMARY

The Clinical Research Coordinator II (CRC II) is primarily responsible for coordinating the operational aspects of ongoing clinical projects to ensure that the clients’ goals of time, cost, and quality are met. The CRC II may serve as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. The CRC II may also serve as the project lead responsible for directing internal teams in the execution of the protocol and ensuring that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained on the protocol.

RESPONSIBILITIES

• Oversees compliance with study protocols; manages quality control, completion and submission of study related documentation; prepares reports for study sponsor and regulatory agencies
• Coordinates and performs responsibilities related to research participants including: determining subject population availability, developing informed consent forms and screening materials, screening and recruitment of subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits, completion of subjects’ assessment(s), charting, collection of biological samples (e.g., blood, urine), medical testing (e.g., vital signs), and processing of data and samples collected during subject visits, recognizes, tracking and reporting of adverse events and protocol deviations
• Develops and maintains patient databases, investigational logs, study regulatory documents, including screening and enrollment logs, drug accountability logs, subject identification logs, and site signature and records of drugs administered, medical devices monitored and/or procedures followed
• Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance, develops report formats and tracks subject recruitment activity
• Monitors study expenses and billing for study services, requests change orders/amendments as necessary
• Serves as primary contact with the sponsor regarding overall study conduct, timelines, and budget.
• Prepares, submits and maintains Institutional Review Board (IRB) and /or other regulatory documents and research correspondence.
• Trains clinical staff on study protocols and procedures and supervises the Clinical Research Unit (CRU) staff when the principal investigator or sub-investigators are not present to direct clinical research activity
• Conducts quality control (QC) checks of the work of self and others to ensure that work quality is acceptable, meets protocol standards, and is compliant with regulatory requirements
• Develops, completes and/or maintains site documentation including but not limited to case report forms (CRFs), data clarification forms (DCFs), source files and regulatory documents
• Oversees storage of documents, as appropriate, in temporary and long-term storage in accordance with standard procedures
• Communicates pertinent information to other staff members who may be involved in research (e.g., physicians, laboratory technologists). This includes the development of meetings or materials intended to serve as a resource for other staff.
• Ensures all staff working on a project have been properly delegated by the Principal Investigator and have received adequate protocol training.
• Represents Clinilabs at investigator meetings as needed, attendance at other meetings with study sponsors or their agents as needed
• Responsible for tracking subject recruitment and enrollment and reporting safety issues including SAE tracking
• Oversees the ordering and shipment of study drug supply, ensuring that drug accountability logs are maintained with the Pharmacy.
• Coordinates study start-up activities with the sponsor and internal staff including the Site Initiation Visit.
• Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
• Prepares for, coordinates and hosts site visits made by sponsors or federal agencies during course and at the close of the study and works independently with such parties to ensure source documents and case report forms are complete, queries are resolved, and required regulatory documentation is in place.
• Conducts all work in accordance with Good Clinical Practices (GCPs), Corporate Standard Operating Procedures (SOPs), and principles set forth in the CFR and ICH guidelines.
• Communicates with sponsors and CROs regarding pertinent issues (e.g., deviations and exemptions, enrollment statistics).
• Responsible for study close-out, coordination of data query resolution, and database lock to meet study timelines.
• Other duties as assigned

TRAVELING

Between Corporate New Jersey and New York units, as needed.

Requirements

• The position requires at least a High School Diploma, but a Bachelor’s degree in one of the basic sciences or a related field is strongly preferred.
• Some experience in clinical research is strongly preferred and may be required depending on current needs.
• The position of CRC II requires good management and organizational skills, understanding of medical procedures, exceptional interpersonal skills, the ability to work independently and lead a project specific team, strong computer skills and writing ability.
• The CRC II is expected to serve as the “command center” for assigned research studies, interacting extensively with sponsors, investigators, review boards, and study subjects.
• The CRC II provides leadership and supervision for the research assistants (RAs) and medical techs during the course of research studies assigned to them and they are involved in study assignments and resource staffing for their projects.
• The CRC II must meet course requirements for Good Clinical Practices (GCPs), infection control, handling of hazardous materials, basic cardiac life support (BCLS), and other specific study-related training.

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