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.

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