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Senior Clinical Research Coordinator

2 months ago

Houston, United States Vitalief Full time
Job DescriptionJob DescriptionWHY VITALIEF?
Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials.  As a result, we are seeking a talented and enthusiastic Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’ mission to impact and save lives. 
 
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: Houston, TX

Responsibilities:
  • Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to solid tumor, NeuroOncology trials.
  • Follows and maintains a processing and tracking system for all protocol related paperwork per departmental guidelines.
  • Reviews patient eligibility of potential study cases and assists in obtaining consents.
  • Assists in creating orders and referrals for research studies, coordinating with various collaborators.
  • Schedules patient tests, keeps patients informed about test results and studies. 
  • Coordinates, evaluates, and follows patient participation (retention) on studies, and maintains the adverse events, pill diaries, schedules, and other study related tasks. 
  • Tracks protocol related labs, responses, and research tests.  Ensures tumor measurements are collected per study requirements.
  • Communicates effectively with PI and collaborates with physicians, mid-level practitioners, research nurses and data managers to document patient care and provide status updates on patients on trials.
  • Assists in the collection and evaluation of data and enters data into case report forms, including maintain deviation and SAE logs.
  • Submit SAEs, initial and follow-ups, in a timely manner as required by the protocol the required time frame to IRB and sponsors.
  • Maintains necessary data for audits and monitor visits. Communicates effectively with data coordinators and regulatory staff as needed.

Required Skills:
  • Bachelor’s Degree required.
  • Minimum of 3 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient 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.
  • Oncology clinical research experience is a plus (any experience working with solid brain tumors is a big plus).
  • Compassionate personality and ability to interact with patients in a clear and confident manner.
  • Ability to work on several trials concurrently – 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, hospital, and laboratory staff) 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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