Job Information
Vitalief Senior Clinical Research Coordinator in Houston, United States
WHY 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.
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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