Senior Clinical Research Coordinator

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.

• 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.

• 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.
• Proficient 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.