Clinical research associate Jobs in Mainz

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

Job Overview

Serves as Clinical Research Nurse 2 for the Cellular Therapy Program oncology clinical trials conducted in the Lombardi Clinical Trials Office of the Lombardi Comprehensive Cancer Center at Georgetown University. Incumbent duties include, but are not limited to :

Responsible for overall coordination of assigned clinical trials throughout the trial lifecycle.

Collaborate with investigators and more senior study team members by participating in recruitment and selection of study participants; document and collect data to support protocol screening and determine compliance with eligibility requirements.

Interface with study participants and obtain and document informed consent according to protocol, institutional policies, and regulatory guidelines.

Coordinate or conduct study-related procedures and assessments while maintaining protocol integrity and patient safety and in accordance with Good Clinical Practice (GCP) guidelines.

Assist in the assessment, management, and coordination across the continuum of care (outpatient, inpatient, and home) including triage of phone calls, symptom management, and proactive patient communication.

Document all study related activity, including medical data, in the participant’s medical record and when applicable, the patient research chart, in compliance with protocol and sponsor requirements.

Conduct follow-up with study participants in accordance with established standards and protocols.

Provide clinical and administrative nursing support to CRC and CRN positions.

Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.

Coordinate collection of research specimens per protocol requirements with Clinical Research Coordinators.

Provide patient education about clinical trial participation, treatment, potential side effects, and required testing.

Schedule / conduct in-service training for appropriate staff on assigned clinical trials.

Regularly update the Clinical Trials Management System (CTMS) with patient information and key dates to support responsible financial management of clinical trials with Clinical Research Coordinators.

Collaborate with Data Coordinator(s) to assure the documentation for the clinical trial is complete and accurate; assist with query resolution in a timely manner.

Document and report serious adverse events per protocol and institutional policy.

Act as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors.

Act as a liaison with sponsors during study start-up activities and participate in site initiation visits, monitoring visits, and audits.

Identify potential barriers to patient and physician participation in clinical trials; develop and implement methods to alleviate those barriers.

Actively participate in meetings, task forces, and committees as assigned.

Other duties as assigned.

Perform all duties in accordance with applicable laws and regulations. Adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs. Work in compliance with Human Subject Protection, patient confidentiality / HIPAA, and GCP.

Work Interactions and Work Mode Designation

Clinical Operations Team Manager

Disease Group members : Principal Investigators, Physicians, Clinicians

Lombardi Clinical Trials Office team members : Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory and Tissue Technicians

External department clinicians and staff : Infusion Nurses, Oncology Pharmacists, hospital staff

Clinical trial sponsors, auditors, and study monitors

Requirements and Qualifications

Bachelor’s degree, BLS certification, and RN license in the District of Columbia required

Three to five (3-5) years nursing experience in a hospital, clinic, or similar health care setting required

At least two (1) year of clinical research experience required.

At least one (1) year of oncology and / or Cellular Medicine experience preferred

Experience working inpatient / Intensive Care Unit settings

Knowledge of clinical research, research processes, and Good Clinical Practice (GCP)

Excellent verbal and written communication skills

Excellent organizational skills and attention to detail

Reliable and able to prioritize competing responsibilities

Work Mode Designation

Pay Range :

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is :

$54,616.00 - $100,493.33

Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.

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Submission Guidelines :

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.

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EEO Statement :

GU is an . All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic

Benefits :

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the .