Clinical Research Coordinator

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 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. 

The CRC will assist neurologists and other members of the clinical and research team in the Movement Disorders and Neuromodulation division with the coordination of clinical research studies and clinical care, including drug treatments and observational studies, for patients with Parkinson’s disease and other movement disorders. Duties will include frequent interactions with patients, coordinating and attending complex clinic and study visits, collecting research data and managing databases, collecting/processing/shipping biological specimens, managing research case report forms and supplies, and managing regulatory documents.  The CRC will support management and coordinate tasks for single or multiple clinical research studies.

Incumbent’s 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 services and departments 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.

% 

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

55

YES

Study Coordination and Data Collection

• 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 are properly stored, and required data are 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.

15

YES

Data management and reporting of results

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

5

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
• 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.
• Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
• Ensure integrity and security of samples.

5

YES

5

YES

Study Implementation

5

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%

Required Qualifications:

•    HS graduation and experience in clinical research coordination, clinical research operations, or related research environment involving human subjects.
•    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.
•    Knowledge of clinical research regulations and guidelines, including:
Good Clinical Practice (GCP)
Human Subjects Protection regulations
Health Insurance Portability and Accountability Act (HIPAA)
Institutional Review Board (IRB) processes and compliance requirements
•    Experience coordinating clinical research studies, including participant recruitment, informed consent procedures, study visit coordination, and protocol implementation.
•    Experience collecting, documenting, and managing research data, including completion and maintenance of case report forms (CRFs) and maintaining accurate study records.
•    Ability to accurately execute Clinical Research protocols in a timely manner.
•    Ability to coordinate multiple concurrent clinical research studies and manage competing priorities while maintaining protocol compliance.
•    Experience working directly with research participants or patients, including scheduling visits, coordinating procedures, and maintaining professional communication.
•    Experience collecting, processing, and coordinating the shipment of biological specimens in accordance with study protocols and safety regulations.
•    Strong organizational, analytical, and problem-solving skills, with demonstrated ability to manage detailed documentation and maintain data integrity.
•    Effective interpersonal and communication skills, with the ability to collaborate with investigators, clinicians, research staff, and external partners.
•    Proficiency with Microsoft Office software (Word, Excel, etc.)
•    Excellent problem-solving skills
•    Interest and ability to work with participants in a Clinical Research setting
•    Ability to work onsite depending on project needs
•    Proficiency with standard computer applications and research documentation tools, including electronic medical records and database systems.
 

Preferred Qualifications:

• Familiarity with neurological disorders and understanding a wide variety of neurological testing procedures.
• Prior academic or professional exposure to patient care and clinical research.
• Fluency in the usage of the Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
• Understanding of patient population to create rapport and a relationship, while also giving insight into what is realistic and appropriate for patient participation.
• Bilingual (English/Spanish) or experience with diverse patient populations.
• 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:  Access, Stata, SASS/ SPSS, and Teleform programming platforms.
• 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

• Experience with data management software and procedures is helpful
• Familiarity with basic biostatistics, data reporting, and analytic procedures helpful
• Experience with REDCap and\or Qualtrics programming and survey methodology helpful  

• Prior experience as a Clinical Research Coordinator in an academic medical center or clinical research environment.

• Experience coordinating neurology or movement disorder clinical studies, including Parkinson’s disease research.

• Certification in clinical research (ACRP, SOCRA) or eligibility to obtain certification.

• Experience with clinical trial management systems (CTMS), electronic data capture systems, and electronic health records.

• Experience preparing and submitting IRB applications, amendments, and continuing reviews. 

• Experience participating in study monitoring visits, regulatory audits, or compliance reviews.

• Experience in training or mentoring junior research staff or assistant coordinators.