Research Coordinator

Hackensack Meridian Health; Hackensack (NJ); On-site; USD 35,000 - 50,000; Full time

Job summary

Hackensack Meridian Health is seeking a Research Coordinator to support cardiovascular clinical research trials onsite in Hackensack, NJ. You will coordinate trial activities, assist with IRB submissions, and ensure regulatory compliance across study teams.

The role requires a Bachelor’s degree (or equivalent), 1+ year in clinical research or regulatory roles, and strong communication and computer skills. This onsite position offers comprehensive benefits and opportunities in a leading health

Qualifications

• Bachelor's degree or equivalent work experience.
• Minimum 1+ year of clinical research/regulatory experience.
• Mandatory education on human subject research.
• Excellent written and verbal communication skills.
• Proficient with Microsoft Office and/or Google Suite.

Responsibilities

• Coordinate and perform all duties related to coordination of clinical research trials.
• Assist with IRB submissions and regulatory documents.
• Serve as liaison between investigators and regulatory bodies to ensure compliance.
• Maintain source documents and regulatory binders for assigned protocols.
• Screen subjects, obtain informed consent, and monitor protocol adherence.

Skills

Bachelor's degree

Clinical research experience

Regulatory knowledge

Communication skills

Microsoft Office/Google Suite

Education

Bachelor's degree or equivalent

Human subjects research education

Tools

Microsoft Office

Google Suite

Job description

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 Research Coordinator coordinates and performs all the associated duties associated with coordination and implementation of the conduct of clinical research trials and projects.

This postion will be fully on- site in Hackensack, NJ. The area of focus will be within cardiovascular research.

Responsibilities

A day in the life of a Research Coordinatorat Hackensack Meridian Health includes:

• Assists and conducts literature review, appraisal and grading of evidence and collaborates on proposal development
• Assists in the preparation and submission to institutional review board application.
• May act as a liaison between Institutional Review Board(s) principal investigators, sub-investigators, assuring compliance with regulatory and institutional mandates and regulations inclusive of but not limited to amendments to protocols and/or modifications to study design as appropriate.
• Reports all serious adverse events to sponsor and IRB(s).
• Serves as primary study coordinator ensuring adherence to the research protocol and provides periodic updates to Principal Investigator on study progress.
• Assists in the development of forms, questionnaires, and completes case report forms and maintains source document
• May create and maintain regulatory binders and files for assigned protocols
• Collaborates with the research nurse coordinator in creating source documents
• Screens research subject /participants as delineated in study specific eligibility criteria
• Obtains informed consent
• Assures follow-up on all protocol patients by maintaining updated records, reviewing active patient lists for correct and current materials, and co-investigators of diagnostic tests needed for protocol compliance.
• Performs periodic quality assurance audits to ensure completeness and accuracy of study documents
• Collects data collection, data validation and verification through and continually monitors to assure, investigates and resolves discrepancies.
• Maintains a thorough knowledge of all aspects of protocol including primary clinical aim, method of protocol execution, budgetary and logistic components and contractual requirements.
• Facilitates all audits with staff of HMH, sponsor, FDA and other regulatory agencies.
• Must continually seek and attend educational venues related to governmental regulations, research and data management.
• Identifies the needs of the patient population served and provides service that is specific to those needs (i.e. 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.).
• May be required to draw blood for sample collection.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• Bachelor's degree or equivalent work experience and High School diploma, general equivalency diploma (GED), GED equivalent programs, and/or other Vocational degrees/certificates.
• Minimum of 1 or more years of experience in clinical research/regulatory experience or equivalent.
• Mandatory education on human subject research.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Licenses and Certifications Preferred:

• Association for Clinical Research Professionals Certification.

Minimum rate of $30.92 Hourly

Job Posting Disclosure

HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant work experience. Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.