Assistant Clinical Research Coordinator - 142062

University of California - San Diego Medical Centers; San Diego (CA); Sur place; USD 76 000 - 122 000; Plein temps

Résumé du poste

UC San Diego Health is seeking an Assistant Clinical Research Coordinator in the Pulmonary, Critical Care & Sleep Medicine Division to support IRB submissions, protocol management, data collection, and regulatory tasks for ICU recovery studies.

Under supervision, you will screen patients, coordinate study startup, recruit participants, manage files, and assist with analyses and reporting, while ensuring compliance with FDA, NIH, GCP and HRPP requirements.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• Experience performing clinical research duties in a clinical research environment.
• Demonstrated experience interpreting medical charts and abstracting data from records.
• Experience coordinating study startup activities and regulatory submissions.
• Knowledge of FDA policies regulating clinical trials and HRPP requirements.

Responsabilités

• Coordinate and manage clinical trials, including patient eligibility screening, data collection and analysis, and protocol compliance.
• Process IRB submissions and amendments; assist regulatory submissions and safety reports.
• Communicate with physicians and disease groups; schedule and recruit participants; maintain clinical research files.
• Assist with data preparation, data extraction, and statistical analyses; support onboarding of staff and volunteers.

Connaissances

Clinical research experience

IRB submissions

Data abstraction/data entry

Regulatory knowledge (FDA/NIH/GCP)

Communication skills

Team coordination

Formation

Bachelor's degree or equivalent experience

Outils

Velos

Access

Excel

MS Word

Description du poste

This is a UC San Diego Internal Recruitment open to UCSD and UCSD Health System Staff Only

Pay Transparency Act

DESCRIPTION

TheDepartmentofMedicine(DOM)isthelargestdepartmentwithintheUCSDSchoolofMedicineandisresponsibleforfulfillingtheteaching,research,andclinicalmissionsoftheUniversityofCalifornia,SanDiegoSchoolofMedicine.Thedepartmentemploysapproximately500salariedfaculty,168academicappointees,331residents,fellowandpostdocsand479staffpersonnel.

Under full supervision from Principal Investigator and Sponsored Project Administrator in the Pulmonary, Critical Care & Sleep Medicine Division, the Assistant Clinical Research Coordinator supports the clinical research efforts for a variety of research projects and clinical trials, including studies evaluating multicomponent, patient-centered approaches to improve ICU recovery, sleep, and delirium management.

Reporting directly to Sponsored Project Administrator, responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Will independently process Institutional Review Board (IRB) submissions and amendments. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings.

Additional responsibilities include project coordination which includes administering various assessments; coordinating protocol implementation and modifications; ensuring protocol compliance; maintenance of accurate and complete clinical research files; close monitoring of assessments, interventions and on-going activities of the projects; and propose solutions and strategies to resolve any issues that might arise. The incumbent will also be involved in scheduling, recruitment, preparation of data for processing, data entry, data extraction, statistical analyses, and other research-related tasks, as well as assist with selection and onboarding, and assist with providing oversight of undergraduate volunteers in the lab.

MINIMUM QUALIFICATIONS

• Theoretical knowledge in biology, immunology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.
• Experience performing clinical research duties in a clinical research environment.
• Demonstrated experience interpreting medical charts, experience in abstracting data from medical records.
• Demonstrated experience working in a Pulmonary & Critical Care Office or clinical research environment including knowledge of intensive care medical terminology.
• Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.
• Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
• Demonstrated knowledge of FDA policies regulating clinical trials.
• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
• Experience with clinical trials participant or study subject recruitment.
• Experience coordinating study startup activities.
• Experience with interpretation and understanding of research protocols in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
• Experience maintaining files and keeping records.
• Demonstrated knowledge of IRB and Human Subjects Research requirements, to include the informed consent and Patient's Bill of Rights.
• Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.
• Excellent interpersonal skills, including excellent written and verbal communication skills; ability to with a diverse group of people to include physicians, patients and their families.
• Ability to work independently. Ability to maintain confidentiality.
• Experience completing clinical trials case report forms via hard copy and online.
• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.
• Demonstrated experience using database, word processing and spreadsheet applications.
• Demonstrated experience working with patients in an ICU setting. Knowledge of diagnostic studies used and medications used to treat delirium and sleep disorders.

PREFERRED QUALIFICATIONS

• Certification as a clinical research associate or coordinator.
• Experience working with research bulk accounts.

SPECIAL CONDITIONS

• Must be willing to work with human blood and biohazardous materials.
• Must have access to reliable transportation and be willing to travel to occasional meetings.
• Must be able to work various hours and locations based on business needs. Occasional evenings and weekends may be required.
• Employment is subject to a criminal background check.
• Employment is subject to pre-employment physical for those who work in clinical settings and/or with patients.
• Performs other duties as assigned.
• Complies with all policies and standards.
• Complies with the University of California, San Diego Health (UCSDH) Principles of Community.
• This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Annual Full Pay Range: $75,815 - $121,960 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $36.31 - $58.41

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).