Clinical Research Coordinator (Osher Center)

Job Summary

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 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. This position will primarily support Dr. Felder's research focused on maternal sleep, mood, parent-child interaction, and child social-emotional outcomes.

The employee's main responsibilities pertain to study implementation, including: implementing study protocols; modifying and managing IRB applications; managing databases and conducting data quality control; distributing survey materials on REDCap; recruiting, enrolling, and retaining study participants; conducting clinical interviews with research participants; conducting experimental tasks with mothers and children; recording study data in REDCap according to good clinical practice; building and/or modifying REDCap database and reports; tracking data collection; coordinating staff work schedules; assisting with training and oversight of other staff and volunteers; assuring compliance with all relevant regulatory agencies; overseeing study data integrity; reporting study progress to investigators; participating in any internal and external audits or reviews of study protocols; and performing other duties as assigned.

The employee must be able and willing to adhere to study guidelines, keep accurate records, maintain confidentiality, and attend regular study team meetings.

Department Overview

The UCSF Osher Center for Integrative Health is an interdisciplinary center that includes clinical, educational, and research programs. Of particular relevance for this position, the UCSF Osher Center is committed to advancing the science of integrative health by conducting and disseminating rigorous research.

Required Qualifications:

• HS graduation and sufficient experience, demonstrated skills, and analytical ability to successfully perform the assigned duties and key responsibilities; and/or equivalent experience/training.
• Minimum one year of experience working directly with children ages 2-5 years in a research, clinical, educational, or related setting, or equivalent experience demonstrating the ability to engage and support preschool-aged children
• Excellent organizational skills and attention to detail
• Strong interpersonal, verbal, and written communication skills
• Strong analytical and problem-solving skills
• Ability to establish rapport with research participants from diverse backgrounds, including mothers and young children
• Ability to work both independently and collaboratively in a fast-paced research environment, prioritize multiple responsibilities, and meet deadlines
• Experience in human subjects research, psychology, child development, behavioral health, psychiatry, or a related field and/or sufficient experience working in a mental health setting
• Ability to facilitate remote research visits via Zoom, including helping participants troubleshoot basic technology issues, guiding caregivers through behavioral tasks with young children, and engaging children 2-5 years
• Proficiency with Microsoft Suite Software, including Word, PowerPoint, and Excel
• Proficiency with Zoom and Box.com platforms
• Flexibility to work occasional evening and weekend appointments if needed

Preferred Qualifications:

• BA or BS in psychology or related field
• Experience conducting structured or semi-structured interviews
• Experience conducting suicide risk assessments
• Experience conducting behavioral experiments with children ages 2-5 years
• Experience working with mothers, young children, and/or perinatal populations
• Experience with REDCap
• Knowledge of human subjects research regulations, including HIPAA and good clinical practice guidelines

Study Coordination and Data Collection (50%)

• Collect study outcome data with structured clinical interviews with high fidelity while maintaining a strong rapport with participants
• 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.

Data management and reporting of results (20%)

• 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.
• 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.

Staff training (5%)

• 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

Quality control procedures (10%)

• 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

Study Implementation (5%)

• Suggest modifications to the administrative infrastructure to accommodate the increasing complexity of studies.
• Modify data collection instruments
• Help schedule staff time and coordinate staff schedules.
• Maintain subject tracking systems.

Protocol Submissions and Adherence (5%)

• 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.

Regulatory responsibilities (5%)

• 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.

Study Coordination and Data Collection (50%)

• Collect study outcome data with structured clinical interviews with high fidelity while maintaining a strong rapport with participants
• 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.

Data management and reporting of results (20%)

• 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.
• 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.

Staff training (5%)

• 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

Quality control procedures (10%)

• 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

Study Implementation (5%)

• Suggest modifications to the administrative infrastructure to accommodate the increasing complexity of studies.
• Modify data collection instruments
• Help schedule staff time and coordinate staff schedules.
• Maintain subject tracking systems.

Protocol Submissions and Adherence (5%)

• 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.

Regulatory responsibilities (5%)

• 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.