Clinical Research Coordinator

3 months ago

Middlesex, United States Hackensack Meridian Health Full time

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.

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).

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

  • Director, Member Scientist Clinical Research

    4 months ago

    Middlesex, United States Hackensack Meridian Health Full time

    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...

  • Clinical Risk and Loss Prevention Specialist

    4 months ago

    Middlesex, United States Hackensack Meridian Health Full time

    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...

  • Registered Nurse

    6 months ago

    Middlesex, United States Hackensack Meridian Health Full time

    Overview The Registered Nurse functions as a caregiver for a specific patient population in order to achieve desired outcomes. This position focuses on expanding knowledge and skills, provides effective direct care as part of the interdisciplinary team to a variety of complex patients. This position directs and oversees the care provided by other...

  • Registered Nurse

    3 months ago

    Middlesex, United States Hackensack Meridian Health Full time

    Overview Responsible for all aspects of patient care from pre-procedure through post-procedure phase. Responsibilities A day in the life of an Orthopedic Coordinator in the Operating Room at Hackensack Meridian includes: 1. Acts as a Preceptor, as assigned, for new staff members: Supports a training philosophy and acts to facilitate this...

  • Registered Nurse

    6 months ago

    Middlesex, United States Hackensack Meridian Health Full time

    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...

  • Registered Nurse

    5 months ago

    Middlesex, United States Hackensack Meridian Health Full time

    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...

  • Home Care Intake Coordinator Nurse

    2 weeks ago

    Middlesex County, United States VNACJ Community Health Center Full time

    Overview The VNA Health Group. We're moving healthcare forward. Move forward with us. As you help us move healthcare forward, you'll enjoy: * A tuition reimbursement program will assist you getting that degree you've always dreamed of. * Continuing Education and online learning programs to keep you current, with certifications to help you master your...

  • Records and Information Management

    4 weeks ago

    Middlesex, United States State of Vermont Full time

    Overview The Vermont State Archives and Records Administration (VSARA) seeks an innovative, versatile and service-oriented information professional to provide reference and research services to a wide range of internal and external stakeholders seeking access to, or information from, records preserved in the state archives. The ideal candidate for this...

  • Records and Information Management

    4 weeks ago

    Middlesex, United States State of Vermont Full time

    Overview The Vermont State Archives and Records Administration (VSARA) seeks an innovative, versatile and service-oriented information professional to lead, manage and provide reference and research services to a wide range of internal and external stakeholders seeking access to, or information from, records preserved in the state archives. The ideal...

  • Pharmacist - Per Diem (JFK Medical Center)

    6 months ago

    Middlesex, United States Hackensack Meridian Health Full time

    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...

  • Assistant Nurse Manager

    6 months ago

    Middlesex, United States Hackensack Meridian Health Full time

    Overview The Assistant Nurse Manager (ANM) is a professional, registered nurse who is a skilled communicator, collaborator and authentic leader. The ANM supports the organization in the execution of the nursing strategic plan and priorities. The ANM actively participates in unit and hospital decision-making and provides meaningful recognition to others....

  • Hospice Social Worker

    4 days ago

    Middlesex, United States Swan Hospice Full time

    Swan Hospice - Swan Hospice is actively seeking a Full/part Time / Per Diem MSW to join our team in Central New Jersey. We provide quality hospice care to patients in skilled nursing facilities, assisted living facilities and in private homes. A. BASIC PURPOSE This is a professional position responsible for the provision of a wide range of psychosocial...

  • RN Case Manager Hospice

    2 weeks ago

    Middlesex County, United States Insight Global Healthcare Full time

    Job DescriptionJob DescriptionAre you looking for a position that allows you to build relationships, coordinate care plans, and travel? Insight Global is seeking a Registered Nurse, RN, to be a member of the interdisciplinary team who work together to meet the physical, medical, psychosocial, emotional, and spiritual needs of hospice patients and families...

  • Human Resources Administrator

    6 days ago

    West Middlesex, United States WernerCo Full time

    Human Resources Administrator ID 2024-1919 Category Human Resources Position Type Regular Full-Time About Us WHY Pro-Driven Brands ? BECAUSE WE ARE THE PRO'S CHOICE! You will find our market leading products and brands on trucks and job sites all over the world. Focusing on end users' needs drives...

  • Clinic Medical Assistant

    2 weeks ago

    Old Saybrook, CT, Middlesex County, CT; Connecticut, United States Middlesex Health Full time

    Position Highlights Department: MHPC Essex Hours: Per Diem Shift: Shift 1 Position Summary: The Medical Assistant (MA) is an integral part of the patient care team. Under the direction of the Practice Manager, the MA performs certain clinical duties, and assists the Providers to assure each patient is provided timely and effective care. The MA...