1 Job in Neptune, NJ
Hackensack Meridian Health is Hiring a Senior Clinical Research Coordinator Near Neptune, NJ
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 Senior Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, and implementing a compliant study conduct according to all relevant local, federal, and state regulatory requirements and institutional Policies 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 the role is assigned. This role is responsible for providing coverage and acting as back-up Project Manager for applicable division, as needed. In addition, this role will serve as preceptor and primary trainer for all newly hired Clinical Research Coordinators.
ResponsibiltiesA day in the life of a Senior Clinical Research Coordinator at Hackensack Meridian Health includes:
- Responsible for precepting and training of Clinical Research Coordinators.
- Serves as primary back-up and direct coverage for Project Manager, as needed.
- Designs, develops, and coordinates clinical trial workflows to assist with administrative clinical trial conduct, and assists Project Manager with implementation.
- Serves as one of main points of contact for sponsors and internal departments to ensure quality data collection and clinical trial conduct, including directly assisting with internal or external audit responses.
- 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 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. Oversees 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. Including, but not limited to communicating with sponsors and their representatives, the IRB and other medical personnel.
- 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, informs investigators of problems, or assists 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, participates in continuing education activities, or attends 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.
- BA/BS diploma/degree in science or healthcare field.
- Minimum of 2 years experience in a Clinical Research Coordinator role, or at least 6 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 on human subject research and GCP.
- SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
Job Summary
Full Time
Ambulatory Healthcare Services
$79k-109k (estimate)
06/07/2024
07/04/2024
hackensackmeridianhealth.org
OAKHURST, NJ
50 - 100
2016
ROSE F HAYET MD
$10M - $50M
Ambulatory Healthcare Services
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About Hackensack Meridian Health
Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two childrens hospitals - Joseph M. Sanzari Childrens Hospital in Hacke ...
nsack, K. Hovnanian Childrens Hospital in Neptune; nine community hospitals Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital Carrier Clinic in Belle Mead; and two rehabilitation hospitals - JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick. Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 35,000 team members, and 7,000 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.
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The job skills required for Senior Clinical Research Coordinator include Clinical Research, Clinical Trial, Customer Service, Presentation, Radiology, Data Collection, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Clinical Research Coordinator. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Clinical Research Coordinator. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Clinical Research Coordinator positions, which can be used as a reference in future career path planning. As a Senior Clinical Research Coordinator, it can be promoted into senior positions as a Clinical Research Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Clinical Research Coordinator. You can explore the career advancement for a Senior Clinical Research Coordinator below and select your interested title to get hiring information.
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