Assistant Clinical Research Coordinator

%

of time (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

30

YES

Receive training on how to, and work under CRC and investigators to:

• 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.
• 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.

30

YES

Data management and reporting of results

Receive training on how to, and under supervision with a CRC:

• Abstract clinical data from medical records (i.e. procedures, lab tests, and other subject-related participation) enter data onto case report forms for The Primary Ciliary Dyskinesia Foundation and the Bronchiectasis Patient Registry in a timely manner.

• Develop and maintain Excel spreadsheets

• Prepare reports from Apex reports on clinic attendance and health screening

• Address and resolve data queries

• Identify, investigate and resolve data quality issues

• 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 Investigators.

• Receiving training to manage and maintain RedCap data entry and extraction

• Receive training to manage and maintain QuesGen database

• Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.

• Help obtain participant biospecimens and receive training to process for storage.

15

YES

Protocol Submissions and Adherence

Receive training on how to, and work under CRC and investigators to:

• Enter all existing and new study protocols into the Committee on Human Research (CHR) online system and external IRB systems; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts.
• 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 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

Quality control and Regulatory responsibilities

Receive training on how to, and work under CRC and investigators to:

• 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
• 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.
• 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.
• Suggest modifications to accommodate increasing complexity of studies.
• Modify data collection instruments
• Maintain subject tracking systems
• Assess feasibility of new proposed studies

5

YES

Study Implementation

Work under supervision with a CRC to:

10

YES

Biospecimen processing

Receive training on how to, and under supervision with a CRC/PI:

• Ensure integrity and security of biospecimens.
• Collection, transfer, and preliminary processing of biospecimens per laboratory best practices and biosafety regulations.
• Maintain database structure and linkage of biorepository-clinical repository using best research practices, data integrity standards, and HIPAA compliance.

5

YES

Miscellaneous

Helps prepare for audits/monitoring visits by sponsors and/or regulatory agencies

Attend quarterly meetings with COPD foundation and PCD foundation to receive updated protocols and collaborative conversations of data quality

Help prepare annual reports to COPD Foundation for Care Center grant.

Maintains and updates materials and resources supporting INTEGRATE

Monitors study supply inventory and reorders as needed

Maintains research charts and study binders; and performs other related duties as assigned.

Receive training and under direct supervision participate in the renewal, modification, and submission of CHR applications and protocols.

Assist with the quality assurance/modification of protocols or UCSF CHR applications.

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%.)