#140135 Lead Clinical Research Coordinator - Medicine

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 Adm Vice Chair of Cardiovascular Clinical Research and Clinical Research Supervisor, the Lead Research Coordinator will independently coordinate and will be accountable for the overall administration and outcome of multiple clinical studies, requiring advanced-level knowledge and skills, involving human subjects that are being conducted in the UCSD Cardiovascular Institute. They will provide leadership to lower level clinical research coordinators, clinical research coordinator assistants 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 Lead Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-IV research studies in Cardiology Clinical Trials as well as lead, direct, and coordinator operational efforts. They will act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. 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. They 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 based on the local and study guidelines, 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.

• Advanced knowledge of experimental protocols, data gathering, protocol design and evaluation.

• 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.

• 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 10-15 years of demonstrated experience working in clinical research environment as a clinical research coordinator.

• At least 5 years of demonstrated experience working with patients with cardiovascular diseases either in a clinical or research setting. Knowledge of diagnostic studies used, and medications used to treat Cardiovascular diseases.

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

SPECIAL CONDITIONS

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

• 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.

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational — or "bench-to-bedside" — research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer.

a. "Misconduct" means any violation of the policies governing employee conduct at the applicant’s previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer. For reference, below are UC’s policies addressing some forms of misconduct:

• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy
• Abusive Conduct in the Workplace