Research Associate

CentraState Healthcare System, headquartered in Freehold, New Jersey, is a leading nonprofit healthcare provider dedicated to serving the community. Its comprehensive network includes CentraState Medical Center, a community-focused hospital, along with an ambulatory campus, two senior living facilities, three free-standing community health pavilions, and a charitable foundation. As the third-largest employer in Monmouth County, CentraState has earned repeated recognition as a Great Place to Work-Certified company, reinforcing its reputation as an exceptional workplace.

CentraState has an employment opportunity available for a Research Associate. This role administers professional research standards in accordance with hospital policies and in alignment with the guidelines of the National Institutes of Health and the U.S. Food and Drug Administration (FDA). The Research Associate ensures patient safety and protection while maintaining a high level of clinical research quality.

Responsible for all IRB processes (local, central or partner facility).
• Participates in site feasibility and protocol activation meetings.
• Ascertains that there is documented Institutional Review Board (IRB) approval for protocols prior to activation meeting.
• Actively participates in selection of appropriate patients for study in collaboration with physician.
• Administers patient evaluation and assessment tests as appropriate.
• Completes the pre-study work including preparation of internal study binder, source document development and case report form development if necessary.
• Develops the calendar for the protocol.
• Participates in protocol activation meetings.
• Ascertains that pretreatment and eligibility of the protocol have been met including a completed informed consent obtained prior to registration. Responsible for the patient receiving a signed copy of the consent form.
• Abstracts data from various sources to retrieve the necessary information to complete eligibility checklists, pre-study flow sheets, pathology reports, etc to confirm patient eligibility.
• Review pre-study information to confirm eligibility and register the patient.
• Documents the patient registration in the database. Places patient name and calendar in the internal study binder.
• Reviews protocol enrollment forms for patients entered onto trials by affiliate investigators, reviews copies of eligibility test results provided by affiliate investigators, and confirms eligibility prior to protocol initiation.
• Reinforces explanations of clinical trials to patients, significant others and personnel.
• Assists in the reporting of adverse events and completion of required forms.
• Maintains current knowledge of protocols, eligibility requirements, and amendments.
• Completes pharmaceutical company Case Report Forms and cooperative group flow sheets.
• Maintains active and follow up list of patients.
• Obtains data from outside sources (physician offices/hospitals) as needed for data collection and submission.
• Obtains all data information from affiliate centers. Ensures that they are following the protocols correctly. Provides them with a calendar to follow.
• Maintains, updates records on protocol patients.
• Prepares a follow-up calendar for the appropriate protocols.
• Obtains and submits x-rays, operative/pathology report, or other specialized reports as needed.
• Submits pathology or other lab materials and appropriate forms when required.
• Notifies the appropriate physician, staff, and the Director of Pharmacy of all serious adverse events (SAE). Compiles all necessary forms related to SAE's.
• Completes and submits all follow-up forms for cooperative groups and pharmaceutical clinical trials.
• Acts as a resource to all personnel to assist in maintaining protocol compliance re study calendar dose modifications, etc.
• Maintains all protocol related items organized, including patient charts, shadow charts and Case Report Forms.
• Participates in all necessary meetings required for the specific tumor study group.
• Acts as liaison with sponsor organization and pharmaceutical companies coordinating research studies.
• Attends and participates in clinical research meetings.
• Evaluates protocol study forms for completeness, accuracy and compliance to protocol.
• Complete Quality Assurance form for calendars, eligibility checklists and source documents.
• Review records and forms prior to an audit.
• Gather records, reports, radiographs, scans and other necessary materials required at the time of site visits by cooperative groups, pharmaceutical companies, or the FDA.
• Communicates effectively with staff and others.
• Anticipates and responds to the needs of others, providing assistance in a courteous quick manner.
• Assists in the promotion of team work.
• Responds appropriately to incoming communications.
• Consistently abides by the Food and Drug Administration (FDA) and IRB policies and procedures.

• Bachelor's degree in related healthcare field required.
• Previous experience in clinical research preferred.
• Research Certification through Association of Clinical Research Professionals or Society of Clinical Research Professionals required.
• Strong professional, organizational, and interpersonal skills to effectively relate with all members of the healthcare team.

CentraState Healthcare System, in partnership with Atlantic Health System, is a fully accredited, not-for-profit, community-based health system dedicated to providing comprehensive health services in central New Jersey. Beyond offering a wide range of advanced diagnostic and treatment options, CentraState is committed to being a valuable health partner, focusing on disease prevention, promoting healthy behaviors, and helping individuals of all ages live well.

Located in Freehold, CentraState includes a 284-bed acute-care hospital, a dynamic health and wellness campus, two award-winning senior living communities, a charitable foundation, and convenient satellite health pavilions. These pavilions offer primary care, specialty physician practices, and access to outpatient services such as lab work and physical therapy.

CentraState is proud to be among the less than two percent of hospitals nationwide to earn Magnet designation for nursing excellence five times. Additionally, it has been recognized as a Great Place to Work-Certified Company by Great Place to Work for four consecutive years.

Joining CentraState means becoming part of a pioneering healthcare facility committed to high-quality, patient-focused care. We invite you to make a difference in our community and advance your career with us. We support our employees with work/life balance initiatives, tuition assistance, career advancement opportunities, and more.

Discover why our employees love their jobs and being part of the CentraState family!

CentraState Health System offers a competitive and comprehensive Total Rewards package that supports the health, financial security, and well-being of all team members.

What We Offer:

• Medical, Dental, Vision, Prescription Coverage (30 hours per week or above for full-time and part-time team members)
• Life & AD&D Insurance
• Long-Term Disability (with options to supplement)
• 403(b) Retirement Plan with employer match
• 401(a) Retirement Plan with employer contribution
• PTO
• Tuition Reimbursement
• Well-Being Rewards
• Employee Assistance Program (EAP)
• Fertility Coverage, Healthy Pregnancy Program
• Flexible Spending & Commuter Accounts
• Pet, Home & Auto, Identity Theft and Legal Insurance
• Growth Opportunity and Workforce Development Initiatives
• Continuing Education / Onsite Training
• A warm, welcoming company culture based upon mutual respect and a collaborative goal of providing excellent patient care
• Concierge Services with Work & Family Benefits
• Magnet recognized healthcare facility

Compensation Range: $35.00 - $59.50 per hour

The compensation above reflects the established range from CentraState Healthcare System (CSHS) for this position at the time the job was posted. CSHS considers many factors to determine compensation, including education, experience, skills, licenses, certification, and training. As such, team member compensation may fall outside this range.

Additionally, the compensation range reflects base salary and does not include extra shift rates or incentives tied to quality, productivity, etc., as applicable.

The benefits outlined also reflect CSHS' policy at the time of posting. Benefits as are made available to other similarly situated team members of CSHS, although participation is at all times in accordance with and subject to the eligibility and other provisions of such plans and programs. CSHS may modify its benefits plans or programs at any time.

CSHS is proud to comply with all pay equity and pay transparency laws.