Lead 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 a problem-solving, enthusiastic Lead Clinical Research Coordinator (as a full time, fully benefited Vitalief employee) with a minimum of 2 years of experience within a hospital setting to join our exceptional client team to support a groundbreaking research surgery pilot project for our client.  As part of this pilot protocol, you will work with the Vitalief team in conjunction with our client’s CRC team and play a key role in preparing for a future clinical trial. 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 Lead CRC will perform protocol-specific tasks including: Surgical patient screening, obtaining informed consent, collection of protocol required imaging, study follow-up both in-patient and out-patient and data entry.
• Evaluate processes throughout the research pilot project, and recommend Standard Operating Procedures (SOPs) improvements, including optimal data collection methods.
• 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 elective surgical cases scheduled, emergent cases and be available on a rotating basis for unanticipated trauma cases, some which may occur during evenings/nights and weekends.
• 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.
• Work and communicate effectively with study monitors to review study data as required.
• Maintain necessary data for audits. Communicate effectively with data coordinators and regulatory staff as needed.

• Bachelor’s Degree is required.  Master’s degree is a plus, ideally in the healthcare field.
• Minimum of 2 to 3 years of experience in clinical research as a Senior/Lead Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol.
• Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines.
• Ability to analyze and recommend clinical research Standard Operating Procedures (SOPs) improvements.
• Experience training / onboarding clinical research coordinators and junior team members.
• Surgical or acute care clinical research experience is a plus.
• Compassionate personality and ability to interact with patients in a clear and confident manner.
• Ability to work on a rotating schedule to cover evenings/nights/weekends as needed within the coordinating team– can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills.
• 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.
• Needs to be communicative and responsive and know when to escalate and communicate issues to management.   
• 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.