Clinical Research Program Manager Jobs in Kentucky

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Requirements

Job Overview

The Clinical Research nurse, Lombardi Cancer Center - Georgetown University, is a position in the benign Hematology clinical research program. Under the guidance and supervision of the Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Georgetown University policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. The clinical trial nurse also acts as study coordinator for research studies.

Additional duties include but are not limited to:

• Ensures compliance with each study's protocol. Participates in recruitment and selection of study participants.

• Provides patient education and medical information to study patients

• Supports the regulatory staff in the maintenance of regulatory documents

• Communicates and collaborates w/ study team including internal and external parties

• Develops accurate source materials

Work Interactions

As an employee of Georgetown University, the Hematology Research program directly supports the University's mission of cura personalis. Clinical Trials offer a unique opportunity for a patient to receive personalized and comprehensive care in a manner that they may not experience otherwise as a patient. Per the requirements of each clinical trial protocol, the research personnel are required to be the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours. The research nurse is instructed and required to maintain regular contact with each patient in their respective trials, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity. As such, clinical trial patients develop close relationships with the research nurse for a trial, which provides unprecedented access to care when necessary.

Operationally, the Research Nurse coordinates with other centers such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), the Research Pharmacy, the Radiology Center, Center of Medicine and Bone marrow transplant. By interacting with other centers within the GUMC, the position indirectly supports research-related operations in centers ancillary to hematology.

On a daily basis, the Research Nurse will report to the Center Administrator and Principal Investigator. The Research Nurse is part of a robust team comprised of 8 study team members (including the Research Nurse, the Administrator, 3 Principal Investigators, a Study Coordinator, Hemophilia Research Nurse and a Regulatory Coordinator. The Research Nurse is responsible for managing at least 15 trials out of the overall portfolio of approximately 33 ongoing trials within our center. The portfolio consists of hematologic diseases, gene therapy and immunotherapy protocols. While the Research Nurse's primary direct report is to the Center Administrator, the Research Nurse will also provide project-specific deliverables to others such as, the PI for each trial, study team members, and to the sponsor contact (e.g., the study monitor appointed by the sponsor for each trial).

Requirements and Qualifications

• Valid RN license

• Bachelor of Nursing degree

• Two (2) years of recent clinical nursing experience in a hospital, clinic or similar health care setting

• Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, administering injections, etc.)

• At least one (1) year clinical trials research experience preferred

• Knowledge of medical terminology, drug calculation skills, clinical medicine, clinical trials and GCP concepts

• Detail oriented and meticulous in all aspects of work

• Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative

• Must have professional demeanor, strong communication skills with the public as well as physicians and co-workers

• Ability to work well independently as well as in team environment

• Strong interpersonal, customer service and multi-tasking skills are critical

• Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire

• Possess the ability to work well under pressure, multi-task, and manage deadlines

• Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures

Work Mode Designation

This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Center of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.

Pay Range:

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

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 resumefor each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website for general information about requesting accommodations, as well as information about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 or oeoc@georgetown.edu.

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.

EEO Statement:

GU is an Equal Opportunity Employer. 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 protected by law.

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 Department of Human Resources website.