Richmond University Medical Center

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Day Shift - 10 Hours (United States of America)

Duties: Responsible for working under the guidance of the Principal Investigator and Sub-Investigators and the Director/Manager to participate in the planning, implementation and overall direction of clinical research projects conducted on behalf of sponsors at the RUMC Oncology Center Research. The CRC is required to perform study procedures, to generate, evaluate, review and record study data, to transcribe source data to case report forms, to liaise with sponsor personnel, to maintain a high level of professional expertise through familiarity with the study protocol, investigator's brochure, and related study materials, and to participate in project team meetings. The CRC is required to travel among all the study sites including RUMC/RHN, hospitals and medical offices where studies are conducted. The CRC assists the Principal Investigator and sub-investigator in conducting clinical studies in compliance with applicable regulations and GCP guidelines.

Qualifications: Requires a Bachelor's degree, preferably in a scientific discipline or equivalent experience. RN with NY license and or CCRC Certification is a plus.

General Experience: A minimum of 2 years of experience in clinical research. Knowledge of FDA regulatory requirements is necessary. Good communication skills with the ability to interact with the Principal Investigator, sub-investigators, and other staff of RUMC Cancer Center Research and sponsor personnel. Excellent Computer Skill with Word, Excel, PP. Require to a have valid driver’s license and a personal vehicle.

Clinical Experience: Minimum of 2 years of experience in a clinical research facility or medical institute with experience in research subjects consenting, taking medical, surgical, and medication history. Assist investigators in physical examination and other invasive and non-invasive procedure and data collection. Experience in vital signs, electrocardiogram, venipuncture, stool, urine, other body fluid and processing of laboratory samples. Experience in dispensing and accountability of study medication. Experience in administering and interpreting different health related ratings and questionnaire.

Specific Responsibilities:

• Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator and sub-investigator.
• Prepare and submit the regulatory document to the Sponsor, IRB, and other agencies. Obtain and maintain IRB approval of the study/studies.
• Maintains a regulatory study file or binder for each study protocol.
• Actively involved in recruitment and screening activities of research subjects to evaluate their eligibility for a clinical study.
• Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develops a strategy for implementing study procedures in compliance with the study protocol.
• Visit Study Sites as required, and assist the study personnel with conduct of study.
• Attend Meetings and trainings pertaining to conduct of clinical studies.
• Performs study procedures (e.g., start intravenous lines, venipuncture, obtain biological specimen samples, obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol.
• Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators.
• Records study data in the source documents. Evaluates and reviews study data to ensure accuracy and completeness.
• Transcribes study data from source documents to sponsor designated case report forms or records data for remote data entry (EDC system) if applicable.
• Resolves data queries in conjunction with the sponsor. Actively participate in any sponsor or FDA audit.
• Assists Principal Investigator or sub-investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
• Interacts with sponsor and RUMC senior management on subject recruitment activities and assists RUMC senior management with developing and tracking study budgets.
• Works on complex problems where analysis of situations or data requires an evaluation of numerous variables.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Submit weekly report of study activities and enrollment to the sponsor, and senior management of RUMC.
• Maintains enrollments totals in clinical research trials as mandated by CoC Accreditation program for Cancer Program

Salary Range: $105,000 - $115,000

Employment Non-Discrimination: Richmond University Medical Center is committed to equality of opportunity in all aspects of employment and provides full and equal employment opportunities to all employees and potential employees without regard to race, color, national origin, religion, gender identity, sex, sexual orientation, pregnancy, childbirth and related medical conditions and needs including lactation accommodations, physical or mental disability, age, immigration or citizenship status, veteran or active military status, genetic information, or any other legally protected status.

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