Clinical Research Coordinator

The Airway Clinical Research Center (ACRC) integrates research programs in asthma, COPD, sarcoidosis, and cystic fibrosis, along with current programs sponsored by the National Institutes of Health (NIH) and the pharmaceutical industry. The Clinical Research Coordinator (CRC) will primarily be responsible for assisting with the coordination of NIH-sponsored studies as part of the ACE, SEARCH and PISA Studies, as well as studies selected by the Principal Investigators (PIs) of the ACRC.

The 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 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 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; 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 (CHR) 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.

Responsibilities % of time Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor) 50% YES Study Coordination and Data Collection Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects. Recruit in the community, including medical clinics, support groups, health fairs, and private physicians. Responsible for screening, determining eligibility and scheduling new study volunteers.

Must be detailed in obtaining accurate subject health status and history to evaluate eligibility and appropriateness for study participation. Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures. Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.

Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure. Oversee subject reimbursement; work to resolve discrepancies and issues. Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.

Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups. Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies. Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration. 15% YES Technical procedures Perform study procedures including baseline spirometry; airway reversibility testing, maximal reversibility testing, methacholine challenge, nitric oxide testing, calibration of equipment, sputum induction, allergen skin testing, EKG, processing biological samples such as blood, saliva and sputum, intermediate computer skills to operate hardware and software for several types of equipment (pulmonary function equipment, EKG machine, nitric oxide equipment).

Ensure supplies and consumables remain stocked to carry out study procedures as per protocol (blood tubes and blood collection kits, spirometry filters, etc) Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner, while minimizing errors and queries, as well as preventing protocol violations and deviations. Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.

Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI. Maintain data collection forms for effective data collection, entry, and analysis. Perform queries and analysis in databases.

Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available. 15% YES Data management and reporting of results 5% YES Quality control procedures Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management. Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.

Implement and maintain periodic quality control procedures Arrange the exchange of and transport of specimens with collaborating Investigators and staff. Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications. Ensure integrity and security of samples. 5% YES Specimen Management/ Maintenance 10% YES Regulatory responsibilities Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.

Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments. Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation. Provide support to more senior CRCs for maintaining IRB documentation such as assisting with modifications to study protocols or consent forms. 100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9.

The total sum should add up to 100%.) Required

Qualifications that must be possessed by any candidate to be considered for the position. These qualifications will be included in the job posting and will be used to screen applicants. Please include qualifications that are objective and quantifiable such as years of experience required, educational degrees, etc.

Please list: HS graduation or GED 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. Proven ability to collaborate with people of different professional levels Experience working in a clinical and/or research environment Proficient in Microsoft Office Suite Required Licenses and/or

Licenses and certifications that a candidate must possess to be considered for the position. Please list: N/A

Qualifications that an ideal candidate would possess, but are not minimally required for a candidate to be considered for the position. Please list: BA/BS degree with a major in science or related field and 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 Institutional Review Board (IRB) 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 Active phlebotomy certification Clinical trials management certification (ACRP and / or SOCRA) 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: Good Clinical Practice Guidelines Health Information and Accountability Act (HIPAA) The Protection of Human Research Subjects IRB regulations for recruitment and consent of research subjects

Full time · Day shift