Research Assistant II - JRI - F/T Days - Hackensack Meridian Health

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

As a Research Assistant II (RA II), this position is a research professional working with and under the direction of the Principal Investigators. The RA II supports, facilitates and helps to coordinate research and clinical trial activities, and plays an important role in the organization of the study.

A day in the life of a Research Assistant II at Hackensack Meridian Health includes:

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Collects data as required by the protocol. Assures timely completion of adverse event logs, and Institutional Review Board (IRB) reports. Maintains study timelines. Maintains accurate written and electronic records of research subjects and category groupings. Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. Retains all study records in accordance with sponsor requirements and University policies and procedures. Maintains effective and ongoing communication with sponsor, research participants and Principal Investigators (PI's) during the course of the study. Assists PI's in preparation of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Coordinates with PI's to help ensure that clinical research and related activities are performed in accordance with Federal regulations and university and sponsoring agency policies and procedures. Assists the PI's in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Assists PI's to assure that all key personnel or study staff members have met training requirements. Maintains up to date documentation of training. Collaborates with PI's and institution to respond to any audit findings and implement approved recommendations. Maintains personnel records for study staff members including: investigators, research assistants, graduate students, medical students and volunteers.
• Reviews and comprehends the protocol. Attends investigator meetings as required or requested by the PI. Collaborates with the PI's to prepare IRB and any other regulatory submission documents as required. Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, adverse event logs, and IRB reports. Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
• Perform data quality evaluation to ensure the completeness, accuracy and timeliness of data entry. Communicate with the IT Team with respect to database creation and maintenance. Maintain up to date Data Dictionary.
• Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Education, Knowledge, Skills and Abilities Required:

• Required proficiency in Microsoft Word, Excel, Outlook.

Education, Knowledge, Skills and Abilities Preferred:

• Undergraduate bachelor's degree in a science field is preferred.
• Direct clinical healthcare experience preferred.
• Experience with data analysis and statistical software preferred.
• Preferred but not required - Proficiency in Microsoft Access, PowerPoint, statistical software. Collaborative Institutional Training Initiative (CITI) eligibility.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!