CLINICAL TRIALS RESEARCH MANAGER

Description : Job Summary : Reports to Research Manager with responsibility for managing, directing, coordinating, leading and facilitating multiple clinical research trials, sites, and multi-disciplinary clinical research staff in testing and evaluation of investigational drugs and vaccines and clinical research studies involving specimen collection from human participants.

Works directly with sponsors and investigators. Develops and maintains good clinical practice standards, budgets and staff development programs.

Ensures compliance with organizational SOPs and government regulations for the conduct of research with human subjects.Essential Responsibilities : Collaborates with principal investigators, study sponsors, trial monitors and the KPGA IRB in establishing, implementing and conducting clinical research trials.

Manages the operations of clinical research units at multiple locations. Supervises clinical research staff, assesses their needs, and identifies educational opportunities.

Recruits and hires new clinical research staff. Develops training materials, monitors adherence to KP education and training requirements, and takes responsibility for training new hires.

Performs as point person for decision-making and problem-solving day to day operation of projects, including the resolution of technical problems and questions of research staff, external monitors etc.

Manages the annual performance evaluation process for the clinical research staff. In conjunction with HR and management, coaches and counsels staff who are non-compliant with applicable KP policies, procedures and standards.

Implements and oversees a compliance / quality assurance monitoring program for clinical trials. Collaborates in the management of research data collection involving human participants.

Implements quality assurance programs and develops strategies that improve the quality of research conducted and patient care.

Recommends corrections, remediation and corrective / preventive action plans based on trending and reporting of monitoring or audit findings.

Proactively monitors trial budgets for appropriate use of human and material resources and how to effectively manage resources within study budgets.

Assists in ensuring the delivery of high quality care and service that meets defined KPHP and KFRI standards and consistent compliance with the Nursing Practice Act, Guidelines for Good Clinical Practices, Federal, state and local regulations for the conduct of research.

Basic Qualifications : Experience Minimum five (5) years of clinical trials research involving human subjects. Minimum five (5) years of supervisory responsibility.

Minimum five (5) years of Ambulatory Nursing. Prior experience as a Clinical Research Coordinator for clinical trial(s).

Education Masters degree in nursing. License, Certification, Registration Registered Professional Nurse License (Georgia) Additional Requirements : Knowledge of IRB / research regulatory requirements.

Preferred Qualifications : Nurse Practitioner or Clinical Nurse Specialist.Certification in Human Subjects Protection (post hire).

Certification in Biohazard Materials Transport (post hire).Certified Clinical Research Coordinator (preferred or will obtain post hire).

Experience with quality assurance / compliance program monitoring and training.Knowledge of continuing education and staff development.

Primary Location : Georgia,Duluth,Gwinnett Medical Offices I Scheduled Weekly Hours : 40 Shift : Day Workdays : Mon, Tue, Wed, Thu, Fri Working Hours Start : 08 : 00 AM Working Hours End : 04 : 00 PM Job Schedule : Full-time Job Type : Standard Employee Status : Regular Employee Group / Union Affiliation : NUE-GA-01NUENon Union Employee Job Level : Manager with Direct Reports Department : Regional Office - 9 Piedmont - Research Administration - 2808 Pay Range : $93500 - $121000 / year The ranges posted above reflect the location in the job posting.

The salary range may vary if you reside in a different location or state than the location posted. Travel : Yes, 10 % of the Time At Kaiser Permanente, equity, inclusion and diversity are inextricably linked to our mission, and we aim to make it a part of everything we do.

We know that having a diverse and inclusive workforce makes Kaiser Permanente a better place to receive health care, a more supportive partner in our communities we serve, and a more fulfilling place to work.

Working at Kaiser Permanente means that you agree to and abide by our commitment to equity and our expectation that we all work together to create an inclusive work environment focused on a sense of belonging and wellbeing.

Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.

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