The University of California at San Francisco Department of Neurology is seeking a bright, hardworking individual with strong communication and organizational skills to serve as a Clinical Research Coordinator. Within the Multiple Sclerosis (MS) group and under the supervision of the Clinical Research Manager or Principal Investigator (PI), the incumbent will help recruit, enroll, register, schedule, and retain study subjects. The incumbent will work closely with other CRCs and study investigators to assist in keeping patients on study schedules and must be able to prioritize and handle multiple tasks in a fast-paced environment.

The Clinical Research Coordinator will work independently or with general guidance at the fully qualified journey level, executing, managing, and coordinating research protocols as directed by the Clinical Research Manager and/or Principal Investigator (PI). They may coordinate data collection and operations for multiple concurrent clinical research studies under the guidelines of research protocols, UCSF policies, and regulatory agency standards.

The incumbent’s duties may include, but are not limited to, supporting the management and coordination of tasks for one or multiple clinical research studies, depending on their size and complexity; acting as an intermediary between services and departments while overseeing data and specimen management; managing and reporting study results; creating, cleaning, updating, and managing databases and comprehensive datasets and reports; coordinating staff work schedules; assisting with training of Assistant CRCs; and supporting the Clinical Research Manager and/or PI with oversight of other research staff. They will also manage Investigator’s protocols in the Committee on Human Research online system, including renewals and modifications to protocol applications and the initiation of new studies. Additionally, they will participate in reviewing and writing protocols to ensure IRB approval within university compliance, help ensure regulatory adherence, oversee data integrity, implement periodic quality control procedures, obtain UCSF approval prior to study initiation, maintain all regulatory documents, report progress to investigators, participate in internal and external audits or reviews, and perform other duties as assigned.

% of time	Essential Function (Yes/No)	Key Responsibilities (To be completed by Supervisor)
70	YES	Study Coordination and Data Collection Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects. 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.
10	YES	Data management and reporting of results Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner. 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 Lead CRC CRM and/or PI. Maintain data collection forms for effective data collection, entry, and analysis. Perform queries and analysis in databases. Work with Lead CRC and CRM to maintain complete and accurate data in the study database; analyze the data as they become available.
		Staff training Attend and actively participate in regular team meetings 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 Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies. Modify data collection instruments Help schedule staff time and coordinate staff schedules. Maintain subject tracking systems. 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.
		Quality control procedures
5	YES	Study Implementation
10	YES	Specimen Management/ Maintenance
		Protocol Submissions and Adherence Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts. Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality. Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance. Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators. Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.
5%	YES	Regulatory responsibilities Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. Initiate and follow-up on CHR submissions and modifications; track approval status. Interface with departments to obtain UCSF approval prior to study initiation. Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments. 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.

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 Qualification

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.
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.

Preferred Qualification

Bachelor's degree
Fluency in the usage of the 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 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
- IRB regulations for recruitment and consent of research subjects
- Environmental Health and Safety Training
- Fire Safety Training

About UCSF

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. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence – also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here.

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

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.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy.

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Clinical Research Coordinator

Job Description

Study Coordination and Data Collection

Data management and reporting of results

Study Implementation

Specimen Management/ Maintenance

Regulatory responsibilities

See Your Match Score

More jobs at iazuqy.fa.ocs.oraclecloud.com

More jobs at iazuqy.fa.ocs.oraclecloud.com