Clinical Research Coordinator

Hackensack Meridian Health; Paramus (NJ); On-site; USD 75,000 - 92,000; Full time

Job summary

Hackensack Meridian Health in New Jersey seeks a Clinical Research Coordinator to oversee operations of assigned trials under the PI and regulatory guidelines. You will coordinate study activities, manage enrollment, data collection, budgets, and liaise with sponsors, IRB, and clinical teams to ensure compliant conduct and timely reporting.

Join a leading neuroscience research network advancing therapies for MS, dementia, Parkinson's, stroke and rare disorders, with opportunities to learn from

Qualifications

• BA/BS diploma/degree in science or healthcare field.
• Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research.
• Strong attention to detail and customer service focus.
• Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
• Excellent organizational, presentation, documentation and interpersonal skills.
• Excellent written and verbal communication skills.
• Proficient computer skills that include Microsoft Office and/or Google Suite platforms.

Responsibilities

• Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
• Participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
• Reviews study with PI and/or clinical research nurses to budget outlining standard of care and research costs.
• Oversee subject enrollment to ensure informed consent is obtained and documented.
• Coordinates research activities not limited to scheduling laboratory tests, radiology testing and other medical exams as required.
• Drafts/creates study orders, billing templates and calendars as necessary.
• Schedules subjects for appointments, procedures, or inpatient stays as required.
• Monitors study activities for protocol compliance and regulatory policies.
• Maintains records on each protocol and patient participating in the trial.
• Works with sponsors, IRB and other personnel as appropriate.
• Ensures accurate documentation in trial management systems.

Skills

Attention to detail

Communication skills

Teamwork

Organizational skills

Interpersonal skills

Microsoft Office / Google Suite

Education

BA/BS diploma/degree in science or healthcare field

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 Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned.

Join the forefront of neuroscience clinical research at Hackensack Meridian Health (HMH), New Jersey’s largest and most comprehensive healthcare network. As part of our nationally recognized Neuroscience Institute, you will work alongside world-renowned physician-scientists to bring pioneering clinical research directly to our patients.

From groundbreaking therapies for Multiple Sclerosis, dementia, and Alzheimer’s to cutting-edge interventions for Parkinson's, stroke, and rare neurological disorders, your work will translate directly into life-changing care. HMH is among an exclusive group of institutions pioneering non-oncology cell therapy studies, offering you a rare opportunity to be at the absolute cutting edge of the field.

We are continuously growing and rapidly building a comprehensive center for neuroscience research, care, and industry partnership. In this dynamic environment, you will learn and implement ideas for cutting-edge neuroscience research to shape the future of neurology. Furthermore, you’ll work with pioneer pharma and biotech companies on their advanced clinical trials across all phases. By learning directly from industry pioneers and applying a patient-first approach, you will witness the real-world impact of your research in real time.

Come push the boundaries of science and advance patient care with us.

Responsibilities

A day in the life of a Clinical Research Coordinator at Hackensack Meridian Health includes:

• Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
• In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
• Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required.
• Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary.
• Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols.
• Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
• Registers protocol patients with appropriate statistical centers as required.
• Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
• Acts as principal investigator`s representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel.
• Along with clinical research nurses, maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required.
• Works closely with clinical research finance to ensure study patient`s clinical trial related activities are billed appropriately.
• Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit.
• Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens.
• Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Identifies protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
• Organizes space for study equipment and supplies.
• Participates in the development of study protocols including guidelines for administration or data collection procedures.
• Contacts outside health care providers and communicate with subjects to obtain follow-up information.
• Reviews scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
• Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Attends research meetings and conferences as required.
• Participates in staff meetings and in-service education as necessary.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standard of behavior.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• BA/BS diploma/degree in science or healthcare field.
• Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research.
• Strong attention to detail and customer service focus.
• Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
• Excellent organizational, presentation, documentation and interpersonal skills.
• 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:

• Education on human subject research and GCP.

Licenses And Certifications Preferred

• SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).

Compensation

Minimum rate of $83,782.40 Annually

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.

Job Duties

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.

HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER

All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.

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.