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Manager, Clinical Research
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$114k-148k (estimate)
Full Time | Ambulatory Healthcare Services 3 Months Ago
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Hackensack Meridian Health is Hiring a Manager, Clinical Research Near Hackensack, NJ

DescriptionOur 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 Manager, Clinical Research is responsible for Clinical Data Coordinators and other clinical support staff for all phases of the data collection for the Clinical Cancer Research Department ensuring compliance to all regulatory regulations.
ResponsibiltiesA day in the life of a Manager, Clinical Research at Hackensack Meridian Health includes:
  • Manages Clinical Data Coordinators, Diagnostic Technicians, and other clinical trial support staff: schedules assignments and makes operational decisions regarding staffing levels, workflow, coverage, etc.
  • Holds staff accountable for completion of assigned tasks including weekly and monthly reports to CCRD and Cancer Center upper management.
  • Monitors and measures research staff performance on a daily basis which also includes annual evaluations.
  • Participates in the hiring and terminating of the Clinical Data Coordinators and support staff.
  • Responsible for the evaluation, developing, and implementing corrective action measures for the Clinical Data Coordinators.
  • Ensures that department, all staff, and all research studies are in full compliance with written protocols, SOPs, HUMC Policy, current Good Clinical Practice, IRB policies, FDA regulations, and Joint Commission rules.
  • Ensures that staffing on clinical trials is maintained at agreed upon service level in study protocol, in study budget, and in accordance with department SOPs, to ensure cost effective use of resources.
  • Re-allocates staff if necessary to ensure proper completion of each day's workload. Based on the collaborative analysis of data, develops plans for improvement and coverage.
  • Protocol management: Phase I, II, III, and IV laboratory operations for the Clinical Cancer Research Department up to and including designating CCRD staff and interacting with Medical Center Staff for the purpose of proper execution of a protocol.
  • Responsible for orientation and training of new Clinical Data Coordinators in collaboration with the research nursing educator.
  • Meets with FDA auditors and sponsor representatives as required.
  • Maintains and approves Clairvia staff schedules and all managerial People Soft related activities.
  • Reviews correspondences from sponsors and regulatory authorities (monitoring follow up letters, quality assurance); to ensure all outstanding items are resolved.
  • Works closely with staff and department to ensure corrective action plans for audit deficiencies are resolved.
  • Works on special projects for Clinical Cancer Research Department quality assurance, regulatory affairs and education sections, including submission of standard operating procedures (SOP) for Data Management and Phase I, II, II, IV laboratory procedures.
  • Attends educational offerings and conferences to stay current on best practices.
  • Adheres to HUMC and Departmental organizational and managerial competency requirements.
  • Reports directly to Director Clinical Cancer Research.
QualificationsEducation, Knowledge, Skills and Abilities Required:
  • Bachelor's degree in the sciences.
  • Minimum of 3 years of supervisory experience.
  • Minimum of 3 years of basic science lab work experience.
  • Minimum of 3 years of cancer clinical trial data management experience.
  • Excellent computer and analytical skills (Excel and Word).
Education, Knowledge, Skills And Abilities Preferred
  • Master's Degree in the sciences.
  • Minimum of 5 years of supervisory experience.
Licenses And Certifications Required
  • Society of Clinical Research Associates Certification or Association for Clinical Research Professionals Certification OR must earn certification within (1) year of hire.
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

Job Summary

JOB TYPE

Full Time

INDUSTRY

Ambulatory Healthcare Services

SALARY

$114k-148k (estimate)

POST DATE

06/07/2023

EXPIRATION DATE

09/23/2024

WEBSITE

hackensackmeridianhealth.org

HEADQUARTERS

OAKHURST, NJ

SIZE

50 - 100

FOUNDED

2016

CEO

ROSE F HAYET MD

REVENUE

$10M - $50M

INDUSTRY

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. More
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