Clinical Research Coordinator - POST SCD Program

POST SCD is a clinical research laboratory with a multidisciplinary team and collaborations with local and federal agencies to comprehensively characterize the burden, underlying causes, and risk factors of sudden cardiac death (SCD) in our prototypic, diverse U.S. community.

It is a first of its kind partnership between cardiac electrophysiology specialists and the County Medical Examiner to perform comprehensive autopsies and antemortem medical history review for every incident out-of-hospital sudden death within the County of San Francisco. Learn more about the lab here, .

The Clinical Research Coordinator (CRC) will execute, manage, and coordinate the routine duties of the Postmortem Investigation of Sudden Cardiac Death (POST SCD) research program alongside a team of CRCs under the guidance of the Principal Investigator (PI) and/or study team.

The CRC will perform independently or with general direction to execute, manage, and coordinate upwards of 10 research projects, 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.

CRC 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 research team and collaborators 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.

Responsibilities

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 Examiner's office, trichrome in collaboration with Dr. Phil Ursell's 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 victim's 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 PI's 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 victim's 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 subject's 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
YES
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 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
• 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
Quality control procedures
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%
(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%.)

Qualifications

Required Qualifications:

• High School Diploma; or equivalent experience/training
• Attention to detail; articulate; self-motivated; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with study subjects, team members, other departments and outside collaborators; 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
• Previous research experience and demonstrated skills to successfully perform the assigned duties and responsibilities
• Demonstrated record of excellent attendance and reliability
• Demonstrated ability to exercise tact and discretion in sensitive communications with patients, victim's families, physicians, and others
• Demonstrated positive interpersonal skills and problem-solving abilities
• Ability to work with minimal supervision and exercise discretion, making sound decisions when evaluating urgent situations
• Ability to manage multiple projects simultaneously and report detailed status updates to research team

Preferred Qualifications:

• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
• Familiarity with FileMaker Pro software for data collection and management
• Experience with coding
• Previous budget management experience
• Experience with electronic and hardcopy medical records
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality
• 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: Access, Stata, SAS/ SPSS, and Teleform programming platforms
• Experience with biostatistics and epidemiological analytic techniques
• Bachelor's degree (BA or BS), rigor of science education
• Excellent computer skills and expert familiarity with the following software programs: Microsoft Office (especially Microsoft Excel) and graphic programs (Adobe)
• Science, research, or medical background