OVERVIEW: Vitalief is a leading site solutions partner focused on improving the value and contribution of clinical trial sites and research projects across large multi-center grants.  We are seeking several problem-solving, enthusiastic Senior Clinical Research Coordinators (as full time, fully benefited Vitalief employees) to join our exceptional client team to support a groundbreaking, multi-year research surgery project for our client.  This is an incredible opportunity to gain hands-on experience in an innovative, first-of-its-kind study. Reasons to work for Vitalief: + You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better. + Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees. + We give everyone a seat at the table – we encourage innovation. + Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually. + Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from. Salary Range:  Market competitive - based on experience level.                                                           Work Location:   On-site in New Brunswick, NJ. Responsibilities: + Under the direction of the project leadership, the local site PI and sub-PI, the Senior CRC will perform protocol-specific tasks including: Surgical patient screening, obtaining informed consent, collection of protocol required imaging, IRB submissions, study follow-up both in-patient and out-patient and data entry. + Adhere to Standard Operating Procedures (SOPs), and create SOPs as needed (i.e., process for obtaining informed consent; study subject data collection process, etc.). + Follow and maintain a processing and tracking system for all enrolled study patients and protocol related processes. + Coordinate with participating surgeons at the site to review surgical schedule for trial participants to ensure there is sufficient coverage – the CRC will be required to function in an operation room environment with surgical study patients. + Educate study participants on the technology being utilized and assist with troubleshooting as needed. + Coordinate, evaluate, and follow patient participation/retention. + Track and submit all study adverse events per site protocol. + Communicate effectively with PI and collaborate with physicians, mid-level practitioners, and nurses to document patient care and provide status updates on patients on trials. + Assist in the collection and evaluation of data and enters data into case report forms, including maintaining deviation and SAE logs. + Maintain necessary data for audits. Communicate effectively with data coordinators and regulatory staff as needed. Required Skills: + Bachelor’s Degree is required, ideally in the healthcare field. + Valid Good Clinical Practice (GCP) Certification. + Minimum of 2 to 3 years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, IRB submissions, data management Experience with collecting, organizing, and handling sensitive research data accurately and securely , and Serious Adverse Events (SAEs) are recorded and reported within reporting deadlines outlined in the protocol. + At least one year of experience within a hospital setting is required. + Confident in working in an operation room environment with surgical study patients and capable of troubleshooting and problem-solving as needed. + Surgical or acute care clinical research experience is a big plus. + Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines. + Ability to adhere to Standard Operating Procedures (SOPs), and create SOPs as needed (i.e., process for obtaining informed consent; study subject data collection process, etc.). + Compassionate personality and ability to interact with patients in a clear and confident manner. + Ability to demonstrate versatility, “can do” attitude, and possess strong organizational, time management skills.  Know when to escalate and communicate issues to management.              + Team player - ability to work collaboratively with all team members (i.e., physicians, nurses, OR staff and project leadership to ensure that services are coordinated and delivered to patients in a timely manner. + P roficient in the use of Microsoft office applications and departmental/Institutional electronic data systems. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.   Powered by JazzHR