High school graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
Attention to detail and strong interpersonal, verbal, and written communication skills to coordinate with research subjects, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment while working with a diverse subject population.
Ability to work independently, complete projects on time, and prioritize multiple projects to meet deadlines.
Preferred: Fluency in the Committee on Human Research online iRIS and Research Gateway systems for protocol submission, renewal, and modification.
Preferred: Understanding of the patient population to build rapport and assess realistic and appropriate participation.
Preferred: Knowledge of medical terminology and experience with electronic medical records.
Preferred: Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality, HIPAA, the UCSF research mission, patient safety, and protection of electronic and hard-copy medical records and communications.
Preferred: Knowledge of research policies and guidelines.
Preferred: Knowledge of REDCap and advanced Excel or similar programs.
Preferred: Two years of experience in a clinical research environment.
Preferred: Experience applying Good Clinical Practice Guidelines, HIPAA, the Protection of Human Research Subjects, CHR regulations for recruitment and consent, effective cash-handling procedures, Environmental Health and Safety training, and Fire Safety training.
Preferred: BA/BS majoring in biology, public health, psychology, sociology, or a related field.
Responsibilities
Coordinate single or multiple clinical research studies, including multicenter clinical trials, NIH- and industry-sponsored studies, and investigator-initiated trials; manage study tasks and operations according to protocols and institutional and regulatory policies.
Identify subjects; develop recruitment and retention strategies; obtain informed consent; screen and enroll study subjects; and advocate for patient safety throughout protocol procedures.
Schedule study visits and assessments, collect medical history, administer questionnaires and other assessments, and perform study procedures according to protocols.
Maintain relationships with subjects, address their needs, arrange follow-up appointments, act as an intermediary, and discuss study outcomes with providers to support continuity of care.
Oversee subject reimbursement and resolve related discrepancies and issues.
Coordinate with staff to complete procedures, collect required data, properly store specimens, and ensure correct shipping and labeling.
Coordinate with other studies, staff, and affiliated groups to improve scheduling efficiency and communication.
Review medical charts and electronic records to extract information for studies.
Recommend improvements to patient coordination, data collection and management, protocol adherence, and study collaboration.
Develop and maintain clinical-trial documentation, databases, participant trackers, case report forms, and data-collection forms.
Reconcile subject encounters with billing to ensure accurate billing and compliance and to prevent improper charges to Medicare, private insurers, or patients.
Document participant progress in clinical-trial management systems, electronic medical records, electronic data capture systems, sponsor documents, and internal tracking logs as required by protocols.
Train staff on study-specific procedures to support patient safety and protocol adherence.
Collect and enter data from visits, procedures, laboratory tests, and other participant activities into databases promptly; manage database structures and update them to support data analysis and management.
Create comprehensive datasets and maintain data-collection instruments for data collection, entry, and analysis; address data queries and perform database queries and analyses.
Conduct studies in accordance with applicable regulations, including the Code of Federal Regulations, Good Clinical Practice, UCSF regulations, and departmental standard operating procedures.
Initiate, track, renew, modify, and submit CHR applications and protocols; maintain protocols in the CHR online system and liaise with CHR analysts and study investigators to ensure timely submissions and approvals.
Obtain UCSF departmental approvals before study initiation and maintain regulatory documents and data-submission timelines.
Maintain patient confidentiality when communicating with agencies, sponsors, healthcare providers, studies, and outside departments.
Establish systems to ensure regulatory compliance and safe conduct of clinical research; monitor participants for study-related adverse events and document adverse events and protocol deviations for submission to appropriate departments.
Create and submit IDE applications and act as an FDA liaison for investigator-led clinical trials.
Prepare for, participate in, and follow up on FDA, CHR, NIH, internal, and external audits and protocol reviews; prepare required documentation.
Assist the Principal Investigator with preparing clinical-trial protocols and documentation for the Institutional Review Board, University, and corporate or government sponsors.
Update and document study procedures; develop plans for consistent data collection and entry; and maintain systems for protocol adherence and data quality.
Perform quality-assurance checks, identify protocols or CHR applications requiring modification, evaluate protocols, and implement improvements.
Ensure protocol violations are reported to sponsors and adverse events are reported to the CHR within required timelines.
Maintain the integrity of patient-reported outcomes and ensure biological specimens are properly collected, processed, stored, transported, and handled.
Order and maintain study-kit supplies, track spending, and make day-to-day decisions in support of assigned studies.
Prepare and present study materials to interdisciplinary teams, investigators, and subspecialty units regarding general research procedures and protocol-specific elements.
Participate in regular team meetings and help develop strategies to increase study awareness and participant enrollment.
Complete required UCSF, departmental, and study-specific training; serve as a resource to investigators and clinical research staff on complex and multicenter clinical trials; and assist with training new staff through oversight and guidance.
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; 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; 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.
Required Qualifications
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.
Preferred Qualifications
Bilingual
Fluency in the usage of Committee of Human Research (CHR) online iRIS and Research Gateway 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.
Knowledge of medical terminology and 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 research policies and guidelines
Knowledge of Computer programs needed: RedCap, Advanced EXCEL or like programs
2 years’ experience in a clinical research environment
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
BA/BS with a major in biology, public health, psychology, sociology, or related field
%
of time
Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
80%
Yes
Study Coordination and Data Collection
Responsible for coordinating multiple clinical research studies simultaneously including multicenter clinical trials, NIH and industry-sponsored studies, and local investigator-initiated clinical trials.
Identify subjects, develop recruitment and retention strategies, obtain informed consent, screen and enroll study subjects; assess and advocate for patient safety throughout each protocol procedure
Schedule subjects for study visits, study assessment (e.g., labs, imaging) and/or administer other study related assessments such as questionnaires, collect medical history and perform study procedures according to the study protocol.
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.
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 staff 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.
Develop and maintain required documentation for clinical trials.
Reconciliation of subject encounters with billing to ensure correct billing practices and billing compliance to avoid improper billing of Medicare, private insurance, or patients.
Document study participants’ progress, when applicable, in clinical trials management system, electronic medical record, electronic data capture, sponsor related documents and internal tracking logs/study records as per protocol.
Assist in the development of databases and participant trackers needed to capture specific protocol required data.
Develop and enhance case report forms and data collection forms as assigned.
Provide ongoing study specific training to other staff members to assure patient safety and adherence to the protocol.
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 study protocol; update databases to improve data analysis and management.
Create and maintain comprehensive data sets as requested by supervisor and/or PI.
Maintain data collection instruments (e.g. Case Report Forms) for effective data collection, entry, and analysis.
Maintain subject data and address study specific data queries promptly; perform queries and analysis in databases
Assure studies are carried out in accordance with all relevant regulations including Code of Federal Regulations, Good Clinical Practice, UCSF regulations, and in accordance with Departmental SOPs
Initiate and follow-up on CHR submissions and modifications as assigned; track approval status.
Interface with departments to obtain UCSF approval prior to study initiation.
Maintain regulatory documents, monitor timelines for data submission.
Use sound judgment to maintain patient confidentiality when communicating with agencies, sponsors, healthcare providers, other studies and outside departments.
Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research.
Monitor participants for evidence of study related adverse events.
Create/submit IDE application and act as an FDA liaison for investigator led clinical trial
FDA, CHR, and NIH audit prevention, preparation, execution and follow-up
Participation in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation
Document adverse events and protocol deviations and submit to appropriate departments.
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.
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.
Assist Principal Investigator in preparing clinical trial protocols and required documentation to the Institutional Review Board, the University, and corporate or government sponsors, as needed.
Update, maintain and documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
Develop and maintain systems for assuring protocol adherence and data quality.
Create/submit IDE application and act as an FDA liaison for investigator led clinical trial.
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;
Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR within stated timelines
Maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
Responsible for the maintenance and integrity of the patient reported outcomes
Ensures proper collection, processing, storage, transport, and handling of biological specimens.
Data Management and Reporting
Regulatory
Quality Control
Specimen Management/ Maintenance
15%
yes
Administrative and Communications:
Order and maintain supplies required for study kits, track spending in this area, and make day-to-day decisions in support of assigned studies Prepares and presents study materials to members of the interdisciplinary team, PI (s)/Subspecialty Unit regarding general research procedures and study specific elements of a protocol.
Actively participate in regular team meetings
Recruitment effort: help develop strategies to ensure increased study awareness and participant enrollment.
10%
yes
Staff Training
Remain up to date on all required trainings (E.g., UCSF trainings, Departmental trainings, study specific trainings, etc.)
Serve as a resource for investigators and clinical research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
May assist in training new staff in preparation and conduct of clinical trials by providing oversight and guidance.
No
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%.)