Clinical Research Coordinator POST SCD Program

%

of time

Essential Function (Yes/No )

Key Responsibilities

(To be completed by Supervisor)

30

YES

Study Coordination and Data Collection

• Enroll consent and interview research subjects via SF Medical Examiner collaboration and Sudden Cardiac Death (SCD) survivors at UCSF.
• Once received bank and organize blood and other tissue specimens
• Obtain and manage histology slides and photographs (H&E stain performed in Medical Examiners office trichrome in collaboration with Dr. Phil Ursells office).
• Analyze trichrome slides and enter end results into study database.
• Collect additional data from patient records at source hospital and referring hospitals including phone calls and chart reviews.
• Develop recruitment and retention strategies for study participants and screen and enroll study subjects.
• Search for SCD and trauma victims next of kin.
• Discuss victims donation of cardiac tissue and DNA sample with his or her next of kin. Should they meet criteria for enrollment as per protocol make arrangements for receiving written consent for receipt and manage transfer of research samples to DNA bank at Parnassus and storage in -80 degree C freezer in PIs laboratory.
• Appropriate testing and appointments and/ or phone calls/ e-mails/ faxes.
• Assist with past medical record data collection and review from all available clinics and hospitals. Telephone interview victims family to follow up on obtained history. Interface with San Francisco Fire Department paramedics to obtain paramedic records from enrolled cases. Enter all pertinent information into database.
• Maintain rapport and relationships with subjects families 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 from family members; 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.

25

YES

Data management and reporting of results

• Collect data for subjects past medical 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 and letters for effective data collection entry and analysis.
• Perform queries and analysis in databases.
• Create clean update and format databases.
• Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.
• Assist in analyzing and writing up results in conjunction with the PI.
• Recommend changes to the protocol as indicated.
• Meet with the PI and other research staff at designated times to review results and discuss protocol and research direction.
• Assist PI in preparing results for presentation at Grand Rounds conferences and other forums.
• Prepare slide and poster graphics.

10

Staff training

• 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
• Oversee dataintegrity; 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
• Prepare data distribution agreements.
• 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.
• Manage necessary solutions containers transport systems for specimens
• Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
• Ensure integrity and security of samples.

10

YES

5

YES

Study Implementation

10

YES

Specimen Management/ Maintenance

5

YES

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%