Clinical Research Coordinator

Job Title: Clinical Research Coordinator

Location: Cooperman Barnabas Medical Ctr

Department Name: Cancer Ctr-Research

Req #: 0000238938

Status: Hourly

Shift: Day

Pay Range: $35.00 - $40.00 per hour

Pay Transparency:

The above reflects the anticipated hourly wage range for this position if hired to work in New Jersey.

The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience.

Job Overview:
The Clinical Research Coordinator supports oncology clinical trials by coordinating patient screening, enrollment, and ongoing participation in research studies in collaboration with physicians, research nurses, and the broader clinical research team. This role is responsible for identifying and prescreening potential study participants, managing the informed consent process, registering patients with study sponsors, and ensuring protocol requirements are followed throughout the course of the trial. The coordinator serves as a key liaison between patients, investigators, and sponsors while coordinating appointments, clinical assessments, and study-related procedures. Additionally, the role oversees accurate data entry and maintenance of research records, manages regulatory and reporting requirements, and ensures compliance with institutional policies, IRB guidelines, and federal research regulations.

Qualifications:

Required:

• Bachelor's Degree in a Social Science or related field
• Equivalent education, experience and/or training may be substituted for the educational requirement
• Detail oriented, have excellent organizational skills
• Proficient in computer applications (Word, Excel, Oncore )
• Possess excellent communication and interpersonal skills, be able to maximize resources and be resourceful

Preferred:

• Minimum of three (3) years of clinical research experience
• At least one (1) year of oncology experience
• Association of Clinical Research Professional as a Clinical Research Analyst (CRA) or Society of Clinical Research Associates (SoCRA) certification as a Clinical Research Professional (CCRP)
• Bilingual skills (English/Spanish); speaking, reading, and writing

Scheduling Requirements

• Working Shift: 3 - 4 Shifts Per Week
• Day Shift: 9:00AM-5:00PM
• Per-Diem, based on departmental needs but will not exceed 30 hours per week

Essential Functions:
Patient Referral, Screening, and Registration:

• Collaborates with the clinical research team to ensure timely prescreening of potential subjects and or active cancer patients for all available clinical trials
• In collaboration with the Research Nurse and/or physician, reviews patient s charts and medical history to confirm protocol eligibility and obtains source documents (i.e. medical record documentation) as needed
• Follows the required elements of the informed consent process to ensure that IRB approved informed consent has been obtained, signed, placed in the medical record, and that a copy was provided to the patient
• Obtain informed consent for non-therapeutic studies as assigned in accordance with IRB, GCP, and institutional policies and procedures
• Registers consented research patients with study sponsor (e.g. industry, NCI Cooperative group, etc.) and inputs into the OnCore clinical trials database maintained by the Cancer Institute of New Jersey

Clinical Responsibilities:

• Serves as an essential link between patients and all other members of the research team,
• Answers patient telephone calls
• Correctly processes information for appointment scheduling, answer questions, and assists with problem solving
• This includes but is not limited to triaging emergent/urgent phone calls, inquiries related to the availability of clinical trials, scheduled appointment dates and times, parking, direction, and general CINJ practice information
• Actively identifies, addresses, and communicates to study team and supervisor any challenges with completion of protocol required procedures and/or adherence to protocol required timelines
• Ensures protocol-specific orders are executed accurately, including scheduling and completion of tests and appointments internal or external to the health system as dictated by the protocol and eligibility work-up requirements through the end of study transition to next site of care
• Coordinates patient reimbursement while on clinical trial, including Rutgers issued or study-specific ClinCards
• Coordinates the clinical assessments and patient care of study participants, with the assigned clinical team, investigators, and ancillary departments (such as pathology, radiology, clinical laboratory, surgery, infusion services) as per protocol requirements and ensures adherence to the treatment plan and GCP guidelines
• Documents protocol-related patient contacts, concomitant patient medications, and utilizes applicable institutional templates

Protocol Coordination:

• Drives collaboration with all integrated, academic medical system staff to ensure that services are coordinated and delivered to patients in a timely manner
• In collaboration with the Research Nurse and physician, assists with accurate grading adverse events using the protocol referenced version of National Cancer Inmmon toxicity criteria or protocol specific grading scales
• Completes Serious/Unexpected Adverse Event (SAE) form for all internal and multicenter serious/unexpected adverse events as required by study sponsors, federal requirements and institutional guidelines
• Ensures accurate completion of follow-up SAE reports and that physician attribution has been included in all AE reports
• In collaboration with the Research Nurse and physician, assists with Deviation reporting as per IRB guidelines, institutional policies, and protocol specific requirements
• In collaboration with the Clinical Trial Lab (CTL), ensures study specific bio-specimens procured are collected and processed according to protocol specific guidelines, including the submission of pathology materials, serum, blood, urine and tissues samples, and CRFs
• Understands and anticipates needs of study sponsors
• Serves as study liaison with study sponsors, schedules monitoring visits and conference calls as part of an integrated, academic medical system
• Provides accurate, timely, intelligent responses to sponsors queries

Data and Records Management:

• Acquires all materials, including films, pathology reports, and laboratory reports timely
• Ensures these records are available for the research team prior to appointments
• Maintains research record (e.g. patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for screened and enrolled patients
• Enters data as directed by data capture plan (DCP) into various auditable databases or electronic data capture systems and/or oversees data entry and validation to ensure accuracy of data
• Supports data management process by addressing queries from monitors
• Using OnCore , provides regular reports to the Disease Specific Group (DSG) members and Principal Investigator on all studies to which he/she is assigned

Addition Responsibilities:

• Demonstrates competence in utilizing computerized systems as required (Sunrise Disease/Clinical Manager, Oncore , IDX, TDS, Medical Records database, etc.)
• Demonstrates basic knowledge to accomplish core tasks (SAE completion, access protocol attachments via Oncore , enter charts into Medical Records Database, format and print patient study calendars, etc.)
• Attends Training Programs, Modules, workshop, and seminars sponsored by OHRS as applicable
• Actively participates in disease specific DSG meetings; quality assurance activities such as audits and meetings with the Principal Investigator, when directed by supervisor, to keep up-to-date on departmental objectives
• Participates in task-forces and/or committees as applicable and/or other process improvement initiatives as assigned
• Assists with training, orientation, and precepting new staff members
• Ensures that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol
• Ensures that research protocols are approved by the Institutional Review Board and followed as written
• Maintains up-to-date knowledge and adheres to policies, procedures, guidance, and practice standards set forth by RWJBH, Rutgers Cancer Institute of New Jersey, FDA, and all regulatory bodies
• Documents and maintains mandatory employee requirements such as Blood Borne Pathogens, Right-to-Know, Tuberculosis, Hand-Washing, as defined by Environmental & Occupational Health & Safety Services (EOHSS), Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and other institutional requirements

Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Benefits and Perks:
At RWJBarnabas Health, our employees are at the heart of everything we do. Driven by our Total Wellbeing promise, our market-competitive offerings include comprehensive benefits and resources to support our employees' physical, emotional, financial, personal, career, and community wellbeing. These benefits and resources include, but are not limited to:

• Paid Time Off including Vacation, Holidays, and Sick Time
• Retirement Plans
• Medical and Prescription Drug Insurance
• Dental and Vision Insurance
• Disability and Life Insurance
• Paid Parental Leave
• Tuition Reimbursement
• Student Loan Planning Support
• Flexible Spending Accounts
• Wellness Programs
• Voluntary Benefits (e.g., Pet Insurance)
• Community and Volunteer Opportunities
• Discounts Through our Partners such as NJ Devils, NJ PAC, and Verizon
• ....and more!

Choosing RWJBarnabas Health!
RWJBarnabas Health is the premier health care destination providing patient-centered, high-quality academic medicine in a compassionate and equitable manner, while delivering a best-in-class work experience to every member of the team. We honor and appreciate the privilege of creating and sustaining healthier communities, one person and one community at a time. As the leading academic health system in New Jersey, we advance innovative strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health.

RWJBarnabas Health aims to truly make a unique impact in local communities throughout New Jersey. From vastly improving the health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs of residents in New Jersey-whether that be enhancing the coordination for treating complex health conditions or improving community health through local programs and education.