| || 47801BR |
| || Clinical Research Coordinator |
| || 9335 Clinical Research Coordinator |
| || Mission Bay and Parnassus |
| || Medicine / Cardiology |
| || Monday - Friday, 8:00 am - 5:00 pm |
| || Days |
| || 8 Hours |
| || JOB OVERVIEW
The Clinical Research Coordinator (CRC) will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. The initiative this position supports is expected to take approximately two years.
The CRC’s duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; perform measurements of electronic heart rhythm monitor recordings using tools such as MatLAB or Physionet to program code and conduct analyses of files in MIT, .RAW, .hdr, and/ or .sig files; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator’s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; interface with collaborating investigators within the UCSF system and other institutions around the country; maintain all regulatory documents; report study progress to investigators; and participate in any internal and external audits or reviews of study protocols.
The primary project will be to work with the PI to implement the Aims of a grant focused on elucidating the characteristics of ectopy and cardiac myopathy. Specifically, to better understand the types of premature atrial contractions (PACs) most closely associated with atrial fibrillation and the types of premature ventricular contractions (PVCs) most predictive of heart failure. This will include analyzing digital Holter data. A similar project aimed at identifying the mechanisms by which alcohol may lead to atrial fibrillation will involve analyzing MIT files obtained from Zio patches. There will also be duties related to directly enrolling patients, often applying new devices (such as fitness trackers designed to detect heart rhythm disturbances) in patients undergoing procedures or in patients coming to clinic or enrolled remotely via the Health eHeart Study.
Other important duties will include: identifying and recruiting patients / participants; maintaining all regulatory elements (including CHR requirements); drafting and implementing research protocols; creating and managing data and databases; creating, organizing, and curating data sheets; developing and following operations manuals; working with patients / participants to ensure retention and compliance with protocols; working with physicians and nurses to correctly implement research protocols, including delivering intravenous medicines or placebo (such as from the research pharmacy) to the nurses, physicians or other qualified personnel that will administer them to participants; obtaining electrophysiology measurements (to be trained if needed); fitting patients with Holter monitors, event monitors, and various physiologic sensors (to be trained if needed); processing biospecimens; answering phone calls and emails from patients / participants and collaborating investigators; scheduling patient / participant visits as well as investigator meetings (including coordinating with members of the DSMB and scheduling meetings and preparing documents for those meetings); drafting grants, manuscripts, abstracts, and CHR applications / modifications; working with the research pharmacy to deliver masked drug and placebo; and organizing all study-related materials, including paper and electronic forms. Duties will also include measurements of data obtained from ECG recordings (both surface and intracardiac) and consenting and scheduling patients for various visits.
Please note: The initiative this position supports is expected to take approximately two years.
MEDICINE / CARDIOLOGY
The Division of Cardiology is one of the largest clinical, research and training divisions of the Department of Medicine (DOM) at UCSF. Within the Division are sub-specialty sections for: Adult Congenital Heart Disease; Advanced Heart Failure, Transplant, and Pulmonary Hypertension; Cardiac Electrophysiology; Echocardiography and Cardiac Imaging; General Cardiology, Interventional Cardiology; and Prevention. The Division runs several clinical practices in multiple sites, conducts basic and clinical research, and educates medical students, residents, clinical fellows and postdoctoral scholars through ACGME as well as non-ACGME training programs. In addition, the Division has significant and complex financial and administrative relationships with the Department of Medicine (DOM) and the UCSF Medical Center, as well as large patient care programs in the sections noted above, large clinical, Federal, and privately supported research programs and six faculty laboratories.
The Division has 45 full-time faculty, four non-faculty academics, 36 clinical fellows, three post-doctoral research fellows, seven WOS faculty, two MSP physicians and 57 research support and administrative staff. The Division currently expends over $22 million per year in pursuit of its clinical, research, training, and service missions. While the Division is primarily split between the Parnassus and Mission Bay campuses, fellows have rotations at the Zuckerberg San Francisco General Hospital (ZSFG) and the San Francisco Veterans Affairs Medical Center (SFVAMC).
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.
| || • HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines
Note: Fingerprinting and background check required. Effective March 13, 2017, all final candidate(s) for employment are required to undergo a background check.
| || • Phlebotomy certification
• Venipuncture certification
• At least three months of experience in medical research
• Proficiency with MatLAB, Physionet, or equivalent with ability to manage and directly analyze ECGs, Holters and ECG monitor data in digital formats
• Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
• Proficiency in data management using Excel, Access, or a similar database
• Fluency in the usage of Committee of Human Research (CHR) online iMedRIS system for submission, renewal, and modification of protocols through this system
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation
• Experience with electronic medical records
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
• Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms
• Experience applying the following regulations and guidelines:
o Good Clinical Practice Guidelines
o Health Information and Accountability Act (HIPAA)
o The Protection of Human Research Subjects
o CHR regulations for recruitment and consent of research subjects
o Effective Cash Handling Procedures
o Environmental Health and Safety Training
o Fire Safety Training
| || n/a |
| || Full Time |
| || 100% |
| || The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. |