Clinical Data Specialist jobs in Sayreville, NJ

Overview

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.

The Clinical Data Coordinator, Oncology maintains essential study documents for clinical research studies and enters data onto Case Report Forms and ensures study compliance.

Responsibilities

A day in the life of a Clinical Data Coordinator, Oncology at Hackensack Meridian Health includes:

• Prepares reports and assists with statistical analysis.
• Assists research nurses in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs.
• Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers.
• Obtains and maintains valid Dangerous Goods Shipping Certification.
• Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack Meridian Health.
• Obtains patient consent for minimal risk studies.
• Organizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits.
• Verifies that all patients have provided informed consent prior to entering study specific data.
• Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs. Records accurate data by completing paper or electronic CRFs.
• Resolves data queries accurately and within study specific timeframes.
• Maintain adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely dispose of expired/closed supplies.
• Centrifuges human specimens per study specific laboratory manual guidelines.
• Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations.
• Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in protocol and completes follow-up CRFs.
• Reports the, tracks, and files off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record. Utilizes the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol.
• Prepare reports, including but not limited to enrollment logs which assist with institutional statistical analysis.
• Provides technical assistance and instruction to students, employees, and medical residents.
• Runs reports and reviews study information in the clinical trial management system.
• Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (i.e., age, culture, language, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• BA/BS diploma/degree in science or healthcare field OR minimum of 2 or more years of experience in a related area with High School diploma, general equivalency diploma (GED), and/or GED equivalent programs
• Prior experience in research that includes data abstracting, case report form completion and research regulatory reporting.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Education, Knowledge, Skills and Abilities Preferred:

• Minimum of 3 or more years of experience in research that includes data abstracting, case report form completion and research regulatory reporting.

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

Our Network

Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility

As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.