Clinical Research Coordinator
Job Description
The Clinical Research Coordinator 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.
Incumbent’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; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; coordinate participant visit schedules with other key staff members; 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; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.
Clinical Research Coordinator responsibilities include participant recruitment and developing new recruitment strategies when necessary; coordinating study visits involving human subjects, some with severely compromised health for whom careful safety checks are essential prior to performing study procedures; data entry and frequent quality control checks to ensure data integrity; and resolving data queries.
The Clinical Research Coordinator will act as the Lead Clinical Coordinator for the investigator-initiated studies in the Fahy workgroup, and work with the Principal Investigator, research fellows, laboratory staff, and staff of the ACRC, to ensure these complex studies with human subjects are carried out with utmost precision. The Clinical Research Coordinator will be in charge of liaising with other UCSF departments (e.g. Radiology, Clinical Labs) as it pertains to study needs. The Clinical Research Coordinator will also assist with protocol and resource management and clinical study organization.
The Cardiovascular Research Institute (CVRI) performs cutting edge research illuminating cardiovascular and pulmonary biology and disease and trains clinicians and scientists to become future leaders of these fields. The CVRI provides a home for a wide spectrum of investigation ranging from the most basic science to disease-focused and patient-based research. It also links faculty interested in cardiovascular biology and disease across UCSF programs, departments and campuses. The diversity of CVRI’s faculty and its collaborative culture fosters a multidisciplinary approach to research problems and provides an important bridge between UCSF’s outstanding clinical and basic science departments.
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
- Experience working in a clinical and/or research environment
- Proficient in Microsoft Office Suite
- 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
- Proven ability to collaborate with people of different professional levels
Preferred Qualifications:
- BA/BS degree with a major in science
- One year of experience in administrative analysis or operations research; or an equivalent combination of education and demonstrated skills to successfully perform the assigned duties and responsibilities
- Fluency in the usage of Committee of Human Research (CHR) online iRIS 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 and administering health screening questionnaires
- Experience with internet database entry
- Experience with biological sample processing (e.g. blood, sputum).
- Experience with performing spirometry.
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA 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:
- Good Clinical Practice Guidelines
- Health Information and Accountability Act (HIPAA)
- The Protection of Human Research Subjects
- CHR regulations for recruitment and consent of research subjects
- Effective Cash Handling Procedures
- Environmental Health and Safety Training
- Fire Safety Training