Research Coordinator

Job Title: 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 REQUIREMENTS:

Bachelor s Degree in a social science or related field is required,

Minimum of three (3) years of clinical research experience preferred,

At least one (1) year of oncology experience preferred,

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) preferred,

Bilingual skills (English/Spanish); speaking, reading, and writing preferred,

The ideal candidate will be detail oriented, have excellent organizational skills, be proficient in computer applications (Word, Excel, Oncore ), possess excellent communication and interpersonal skills, be able to maximize resources and be resourceful,

Equivalent education, experience and/or training may be substituted for the educational requirement,

PHYSICAL DEMANDS: Standing, sitting, walking, talking and hearing,

No special vision requirements,

Lifting up to 25 lbs,

WORK ENVIRONMENT: Office environment,

Moderate noise,

1,

Patient Referral, Screening, and Registration:

a,

Collaborates with the clinical research team to ensure timely prescreening of potential subjects and or active cancer patients for all available clinical trials,

b,

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,

c,

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,

d,

Obtain informed consent for non-therapeutic studies as assigned in accordance with IRB, GCP, and institutional policies and procedures,

e,

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,

2,

Clinical Responsibilities:

a,

Serves as an essential link between patients and all other members of the research team,

b,

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,

c,

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,

d,

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,

e,

Coordinates patient reimbursement while on clinical trial, including Rutgers issued or study-specific ClinCards,

f,

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,

g,

Documents protocol-related patient contacts, concomitant patient medications, and utilizes applicable institutional templates,

3,

Protocol Coordination:

a,

Drives collaboration with all integrated, academic medical system staff to ensure that services are coordinated and delivered to patients in a timely manner,

Assists in the promotion of teamwork,

b,

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,

c,

In collaboration with the Research Nurse and physician, assists with Deviation reporting as per IRB guidelines, institutional policies, and protocol specific requirements,

d,

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,

e,

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,

4,

Data and Records Management:

a,

Acquires all materials, including films, pathology reports, and laboratory reports timely,

Ensures these records are available for the research team prior to appointments,

b,

Maintains research record (e,

g,

, patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc,

) for screened and enrolled patients,

c,

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,

d,

Using OnCore , provides regular reports to the Disease Specific Group (DSG) members and Principal Investigator on all studies to which he/she is assigned,

5,

Maintains a high level of professional responsibility and performance,

6,

Strives to grow professionally through continuing education and skill building (interpersonal, computer, technical, etc,

),

Identifies professional goals and action steps to attain during each fiscal year,

7,

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,

),

8,

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,

9,

Assists with training, orientation, and precepting new staff members,

10,

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,

11,

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,

12,

Performs other related duties as assigned,