Clinical Research Coordinator

at  Vitalief

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 Clinical Research Coordinator (CRC) with a minimum of 6 months’ experience within a hospital setting to join our exceptional client team to support a groundbreaking 15-week research surgery project for our client. The project may be extended beyond that timeframe.
As part of this pilot protocol, you’ll 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. While operating room experience is a plus, it’s not required. You will have the support of our lead CRC in that area and more!
If you’re ready to step into an impactful role with a dedicated team, apply now!
Compensation: Market competitive - based on experience level.
Work Location: New Brunswick, NJ

Required Skills:

• Associate or Bachelor’s Degree preferred.
• Minimum of 6 months of experience in clinical research as a 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.
• 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

• Under the direction of the project leadership and the local site PI, the 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.
• 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.

Required Skills:

• Associate or Bachelor’s Degree preferred.
• Minimum of 6 months of experience in clinical research as a 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.
• 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.
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