Clinical Research Coordinator Infectious… at UCSF Health · 1001…

Summary: UCSF Health is a leading institution dedicated to health sciences, and they are seeking a Clinical Research Coordinator for their Infectious Disease department. The role involves coordinating clinical research studies, managing data and specimens, and ensuring compliance with regulatory standards while working closely with study participants and research teams. Responsibilities: - 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 - Prepare laboratory setups and paperwork for specimen collection and tracking - 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 - Assist patients as necessary with reading or computer-literacy deficits when using the self-administered web-based study tool to ensure as consistent a quality as possible in the responses - Clarify questions that may arise from these self-administered health surveys - Provide back-up coverage for other CRCs, under Supervision, in implementing HIV- and PrEP-related clinical research protocols - 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 CRC Supervisor and/or PI - Maintain data collection forms for effective data collection, entry, and analysis - Work with the PI/PD to maintain complete and accurate data in the study database; analyze the data as they become available - Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures - Attend and actively participate in regular team meetings - Document work flow and create/update protocols for training and grant-reporting purposes - 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 - Modify data collection instruments - Help schedule staff time and coordinate staff schedules - Maintain subject tracking systems - Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies - Other administrative duties as necessary e.g., scheduling meetings, taking meeting minutes, filing, purchasing - Setup and maintain petty cash fund of up to $2000 as well as check requests for research subject stipends and manage gift card reimbursements. Follow proper subject reimbursement procedures - Ensure appropriate and accurate charges are applied to the correct study fund. Work directly with accounting department to set up new systems for funding needs as they arise, including developing purchase orders for necessary goods/services - Assist in the management of a complex network of vendors used for study related costs for lab/office supplies, subject transportation, courier and clinical lab services etc - Arrange or perform the exchange of and transport of specimens - Identify and request needed laboratory supplies and place orders in the procurement system - Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications - Ensure integrity and security of samples - 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 - 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 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 - Proficiency in MS Word, Excel, PowerPoint and Outlook Preferred Qualifications: - Experience using Qualtrics and/or Recap for survey administration - Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation - Experience in communicating remotely with study participants (i.e. via email, text, or video chat); 6 months experience in survey research that includes sensitive content, or an equivalent combination of education and experience - Experience with translational research trials, statistics and/or data management; knowledge of clinical research practices and longitudinal cohort studies - Experience working with people living with HIV in a service or research capacity - Experience working with transgender men and women in a service or research capacity - Experience working with culturally diverse groups - Spanish Language Proficiency - Comfortable speaking with subjects on sensitive issues including sexual practices - Demonstrate excellent attendance and reliability - 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: Qualtrics and Redcap programming platforms, Stata and/or R experience is a plus - 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 - Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system - BA/BS or Associate's degree Required Skills: MS Word, MS Excel, MS PowerPoint, MS Outlook, Qualtrics, Redcap, Survey administration, Clinical research practices, Longitudinal cohort studies, Clinical Practice Guidelines, HIPAA, Committee on Human Research (CHR) online iMEDris system, Data management, Stata, R programming, Spanish language proficiency