- Thorough understanding of ICH Good Clinical Practices, clinical trials management and regulatory compliance as it relates to clinical operations. Knowledge of scientific methods, research design, and medical practices ad procedures that would be acquired through experience with human medical research studies.
- Submit start-up meeting documentation, IRB documentation, updates, and safety reports, and pharmaceutical company/CRO documentation and updates.
- Maintain study documentation according to study protocol and FDA regulations: Timely serious adverse event (SAE) reporting, preparedness for monitor/audit visits, timely and organized documentation submissions to principal investigator, organized and accurate source/CRF documentation, maintain FDA/IRB documentation including: 1572, informed consent, and CVs.
- Maintain timely submissions of screening logs, enrollment logs, and referral logs. Maintain high efforts for maximum patient enrollment and retention in clinical trials. Recruit and follow-up with potential study subjects.
- Assure compliance with all FDA regulations and company procedures. Perform proper source documentation, data collection, drug accountability, lab specimen collection, and lab processing for all trials to maintain high quality data input.
- Bachelor's Degree in Healthcare or equivalent experience. Required and
- Master's Degree Preferred
- Candidate must have clinical study site experience (phase I-IV preferred) in order to have a thorough understanding of the processes associated with clinical research operations, regulatory guidelines, and data management. Required and
- 1-3 years Candidate must also have one to three years clinical research coordinator experience. Required
- Strong interpersonal skills, excellent written and verbal communication skills, and planning and organizational skills, the ability to problem solve independently and with others are essential.
- Candidate must also possess ECG, phlebotomy, patient care, intervention, and advanced computer skills.
- Must be able to carry 15-20 pounds of supply from the hospital to a remote site as needed and will be exposed to infectious and hazardous materials.
- RN - Registered Nurse - State Licensure and/or Compact State Licensure Upon Hire Preferred and
- LPN - Licensed Practical Nurse - State Licensure Upon Hire Preferred and
- Certified Clinical Trials Programmer-SAS Upon Hire Preferred
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Description
Holy Name is New Jersey's last remaining independent, Catholic health system, comprising a comprehensive 361-bed acute care medical center, a cancer center, medical fitness center, residential hospice, nursing school, and physician network. The system has a national reputation for providing culturally sensitive care to a diverse population, drawing patients from across the New York City region to its specialty centers and renowned doctors. Holy Name's mission to provide technologically advanced, compassionate and personalized care extends across a continuum that encompasses education, prevention, diagnosis, treatment, rehabilitation and wellness maintenance. The system is known as a high-quality, low-cost provider of extraordinary clinical care given by compassionate, highly trained physicians and staff.A Brief Overview
Primary duties will involve managing studies in a phase I-IV unit including executing study procedures according to protocol, generation and completion of source documents, and completion of case report forms.
What you will do:
Education Qualifications:
Experience Qualifications:
Knowledge, Skills, and Abilities:
Licenses and Certifications:
Holy Name is a mission-driven facility whose quality standards and philosophy are rooted in the principles of its founders, the Sisters of St. Joseph of Peace. Those principles are exercised daily by the Medical Center's dedicated and talented team of physicians, nurses, allied health employees, and a wide variety of non-clinical administrative and operational staff members. Holy Name is an Equal Opportunity Employer.
