Description

JOB SUMMARY

The Clinical Research Coordinator I (CRC I) will primarily work under the supervision of the Senior Clinical Coordinator for coordinating the clinical aspects of ongoing clinical projects to ensure that the clients’ goals of time, cost, and quality are met. The CRC I coordinates with the Senior CRC to ensure appropriate communications to meet study timelines. The CRC I 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; interacts with quality control, review 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, assist 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
• Maintains patient databases (i.e. EDC, Clinical Conductor), study regulatory documents, including screening and enrollment logs, subject identification logs, medical devices monitored and/or procedures followed
• Prepares, review 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
• Develops, coordinates with the Senior CRC to complete 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.
• Responsible for tracking subject recruitment and enrollment and reporting safety issues including SAE tracking.
• Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
• 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 locations, 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 I requires good organizational skills, understanding of medical procedures, exceptional interpersonal skills, and communication skills to assist a Senior CRC on a project specific team, strong computer skills and writing ability.
• The CRC I provides assistance to the Senior CRC with 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 I 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.