H-1B Visa Clinical Research Manager Jobs

INTRODUCTION

This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements.

Position Duties

• Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the following duties:

• Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area

• Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis

• Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors

• With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants

• Completes all tasks required by study sponsors.

• Provides regulatory documents to sponsor in timely manner

• Completes case report forms, data entry, and maintains source documentation for all study participants

• Tracks and reports adverse events per sponsor and institutional guidelines

• Coordinates research monitor visits and responds to all data queries

• Coordinates the process for opening new studies.

• Obtains needed background material(s) on proposed research projects; presents findings and information to principal investigator

• Completes feasibility questionnaires

• Circulates the confidentiality disclosure and trial agreements to the appropriate parties

• Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial

• Assists in development of workflow procedures for study team based on specific protocol

• Participates in recruitment and selection of study participants. Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.

• Coordinates and schedules a variety of medical procedures/tests including, but not limited to, laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests as needed by the study protocol(s).

• In conjunction with the principal investigator, research pharmacist, and other members of the research study team, provides study specific education to the participant and their family. This may include study specific procedures, diary/study log documentation, proper dosage/administration, and disease treatment.

• Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency.

• Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.

• Performs miscellaneous job related duties as requested.

Phoenix Children's Mission, Vision, & Values

Mission

To advance hope, healing and the best healthcare for children and their families

Vision

Phoenix Children's will be the leading pediatric health system in the Southwest, nationally recognized for exceptional care, innovative research and advanced medical education.

We realize this vision by:

• Offering the most comprehensive care across ages, communities and specialties
• Investing in innovative research, including emerging treatments, tools and technologies
• Advancing education and training to shape the next generation of clinical leaders
• Advocating for the health and well-being of children and families

Values

- We place children and families at the center of all we do
- We deliver exceptional care, every day and in every way
- We collaborate with colleagues, partners and communities to amplify our impact
- We set the standards of pediatric healthcare today, and innovate for the future
- We are accountable for making the highest quality care accessible and affordable