Clinical Research Associate

Position Details

Position Information

Recruitment/Posting Title Clinical Research Associate

Job Category Staff & Executive - Research (Laboratory/Non-Laboratory) Department RWJ-Thoracic Surgery Overview

New Jersey's academic health center, Rutgers Biomedical and Health Sciences (RBHS) takes an integrated approach to educating students, providing clinical care, and conducting research, all with the goal of improving human health. Aligned with Rutgers University–New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research.

Our faculty are teachers, clinicians, and scientists with unparalleled experience who advance medical innovation and provide patient care informed by the latest research findings. We offer an outstanding education in medicine, dentistry, pharmacy, public health, nursing, biomedical research, and the full spectrum of allied health careers.

Our clinical and academic facilities are located throughout the state—at Rutgers University–New Brunswick, including Piscataway; and at locations in Newark, Scotch Plains, Somerset, Stratford, and other locations. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, Newark's University Hospital in Newark, and other affiliates.

Through this community of healers, scientists, and scholars, Rutgers is equipped as never before to transform lives.

Posting Summary

Rutgers, The State University of New Jersey is seeking a Clinical Research Associate for the Surgery department within Robert Wood Johnson Medical School. Under the direction of the Program Supervisor, the Clinical Research Associate serves as a member of a multidisciplinary research team and collaborates with the Principal Investigator and Sub-Investigators in coordinating all aspects of clinical research studies. The Clinical Research Associate also utilizes specialized knowledge, skills, and competencies in the sciences and/or patient management not limited to: patient screening and recruitment, protocol implementation; data collection and query resolution; device and drug accountability; submission to the Institutional Review Board (IRB); facilitation of clinical trial agreement execution; assistance with account management of research funds and budget reviews; correspondence with study sponsors and federal regulatory agencies for research; document preparation for site audits; and other related administrative and clerical tasks as assigned.

Among the key duties of this position are the following:

Coordinates the functions, activities, and resources of the Division's clinical research.

Maintains communication with PI and sub-investigators, patients, internal and external collaborators (e.g. consulting physicians), sponsors, federal regulatory agencies, and other involved parties as required.

Provides overall study coordination and ensures protocol compliance per FDA, GCP guidelines, OHRP, HIPAA, IRB and institutional guidelines, and standard operating procedures.

Develops and implements procedures to identify and recruit eligible patients for IRB approved studies.

Ensures study parameters are correctly applied and eligibility criteria are met.

Coordinates and participates in the analysis of study data. Responsible for the extrapolation, collection, compilation, and submission of data. This includes, but is not limited to patient registration, treatment plans, adverse event documentation and reporting, clinical response, and long-term follow-up for all services.

Administers tests and collects data during study visits as needed.

Organizes the development of study files, data management procedures, and logs.

Maintains accurate and/or thorough documentation on all source documents and case report forms (CRFs) for each study patient, resolving all patient queries, reporting adverse events.

Position Status Full Time Hours Per Week Daily Work Shift Work Arrangement FLSA Exempt Grade 24S Position Salary Annual Minimum Salary 62326.000 Annual Mid Range Salary 74738.000 Annual Maximum Salary 88704.000 Standard Hours 37.50 Union Description HPAE, Local 5094 Payroll Designation PeopleSoft Benefits

Rutgers offers a comprehensive benefit program to eligible employees. For details, please go to https:// uhr.rutgers.edu/benefits/benefits-overview. Rutgers also offers a benefit program to eligible full-time postdoctoral fellow students. For details, please go to https: // finance.rutgers.edu/healthcare-risk/insurance/postdoctoral-health- insurance.

Seniority Unit Terms of Appointment Staff - 12 month Position Pension Eligibility ABP

Qualifications

Minimum Education and Experience

Master's Degree in a related field.

Three (3) years of research experience, two (2) of which shall have included university/hospital level clinical monitoring.

Certifications/Licenses Required Knowledge, Skills, and Abilities

Strong research specific knowledge base.

Demonstrated ability to maximize resources on a continued basis.

Must be detail oriented.

Must have excellent organization, communication, and interpersonal skills.

Must hold self -accountable to high standards of professional excellent.

Must have working knowledge of Microsoft Office products (Word, Excel, etc.).

Solid knowledge of computer software programs (Microsoft Office, databases, etc.).

Preferred Qualifications

Experience in a hospital/university/healthcare institution.

Equipment Utilized Physical Demands and Work Environment

PHYSICAL DEMANDS:

Working at a computer, walking, standing, taking elevators or stairs.

WORK ENVIRONMENT:

Hazards include risk of exposure to communicable diseases and operation of equipment.

Potential exposure to Category I risks (blood/body fluid, biological agents) and hazardous chemicals.

Special Conditions

Posting Details

Posting Number 22ST1220

Posting Open Date Special Instructions to Applicants Regional Campus Rutgers Biomedical and Health Sciences (RBHS) Home Location Campus Downtown New Brunswick City State Location Details

Pre-employment Screenings

All offers of employment are contingent upon successful completion of all pre- employment screenings.

Immunization Requirements

Under Policy 60.1.35 Immunization Policy for Rutgers Employees and Prospective Employees, Rutgers University requires all prospective employees to provide proof that they are fully vaccinated and have received a booster (where eligible) against COVID-19 prior to commencement of employment, unless the University has granted the individual a medical or religious exemption. Employees who are not eligible for a booster at the time of an offer of employment must provide proof they have received a booster upon eligibility and upload proof of same. Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate's offer of employment or disciplinary action up to and including termination.

Affirmative Action/Equal Employment Opportunity Statement

It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. For additional information please see the Non-Discrimination Statement at the following web address: https:// uhr.rutgers.edu/non- discrimination-statement

Supplemental Questions

Required fields are indicated with an asterisk ().

Do you have a minimum of a Master's Degree in a clinical research related field plus three (3) years of related clinical research experience, two years (2) of which shall have included university level clinical monitoring?

Yes

No

Applicant Documents

Required Documents

Resume/CV

Optional Documents

Cover Letter/Letter of Application