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Lead Clinical Research Coordinator - 129576

Job Description

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

UCSD Layoff from Career Appointment: Apply by 05/06/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 05/09/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.

Under direction of the Principal Investigator (PI) and Sponsored Project Administrator in the Pulmonary, Critical Care & Sleep Medicine Division, the Senior Research Coordinator will independently coordinate and be accountable for the overall administration of clinical research efforts for a variety of advanced research projects and clinical trials focusing primarily on pulmonary hypertension and related conditions. The incumbent will provide leadership to lower level clinical research coordinators and/or other support personnel.

Key to this role is managing infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation; working with leadership to ensure proper execution.

The Senior Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-IV research studies in assigned disease team as well as lead, direct, and coordinator operational efforts. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Manuscript contributions will include study design, collage/figure design and creation, analysis of manuscript data, and completion and submission of manuscript. The candidate will be responsible for assigned aspects of grant proposal preparation and submission, including technical writing and editing, budget preparation, and aiding in compliance with federal, state and university regulatory requirements for funded research.

Drawing on experience with Industry, National Institutes of Health (NIH), and society sponsored research, the incumbent will determine interest of groups in trial participation, assess ability to execute protocol safely and properly, independently monitor study participant compliance, evaluation and quality assurance procedures, oversee the quality of clinical and research data and write annual reports; oversee the regulatory process for site, Institutional Review Board (IRB), research compliance and Food and Drug Administration (FDA) audits, and ensure compliance of Health Insurance Portability and Accountability Act (HIPAA) regulations of patient confidentiality throughout the studies, manage the acquisition, preparation, and distribution of patient financial compensation.

The incumbent will work with leadership on developing, improving, and implementing study protocols, offering insight at the regulatory, operational, clinical, and technical levels. Incumbent will oversee the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Other duties assigned as needed.

MINIMUM QUALIFICATIONS
  • Advanced theoretical knowledge and Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

  • Clinical Trial Professional certification from a professional society within one year in position.

  • Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

  • Advanced knowledge of investigational protocols especially with pediatric oncology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).

  • Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

  • Advanced knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

  • Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

  • Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

  • Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

  • Strong experience completing clinical trials case report forms via hard copy and online.

  • Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

  • Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

  • Working knowledge of medical and scientific terminology.

  • Proven ability to problem solve and resolve conflict.

  • Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

  • Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

  • Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience conducting searches on the internet.

  • Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

PREFERRED QUALIFICATIONS
  • At least 2 years of demonstrated experience working in a Pulmonary & Critical Care Office or clinical research environment including knowledge of pulmonary medical terminology.

  • Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

  • Bilingual in English and Spanish

  • Possess a Phlebotomy (CPT) Certification

  • At least 2 years of demonstrated experience working with patients with pulmonary hypertension or similar respiratory diseases either in a clinical or research setting. Knowledge of diagnostic studies used and medications used to treat pulmonary hypertension.

SPECIAL CONDITIONS
  • Occasional evenings and weekends may be required.

  • Must be willing to travel to occasional meetings and work weekends and evenings as needed.

  • Must be willing to work with human blood and biohazardous materials.

  • Employment is subject to a criminal background check and pre-employment physical.

Pay Transparency Act

Annual Full Pay Range: $81,334 - $130,784 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $38.95 - $62.64

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).


UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

 

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