University of California - San Francisco
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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 Manager 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, neurosurgeons, neuropsychologist 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 involving drug and surgical treatments, observational and/or neurophysiology 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 Manager 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.
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|
% of time |
Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
|
55 |
YES |
Study Coordination and Data Collection
|
|
15 |
YES |
Data management and reporting of results
|
|
5 |
Staff training
|
|
|
5 |
YES |
Quality control procedures |
|
5 |
YES |
Study Implementation |
|
5 |
YES |
Specimen Management/ Maintenance |
|
5 |
YES |
Protocol Submissions and Adherence
|
|
5 |
YES |
Regulatory responsibilities
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%.) |
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Required Qualifications:
- 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.
- Ability to work onsite full-time
- High school degree
- Familiarity with Microsoft Office software (Word, Excel, etc.)
- Demonstrated ability to maintain professionalism in academic/research environments.
- Demonstrated reliability in attendance and punctuality in an academic/research setting
- Ability to provide 2-3 strong professional references
Preferred Qualifications:
- Familiarity with neurological disorders and understand a wide variety of neurological testing procedures.
- Prior academic or professional exposure to patient care and clinical research.
- fluency in the usage of 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 to what is realistic and appropriate for patient participation.
- experience with electronic medical records.
- Bachelor’s degree in a related field or equivalent experience.
- 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
Required Qualifications:
- 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.
- Ability to work onsite full-time
- High school degree
- Familiarity with Microsoft Office software (Word, Excel, etc.)
- Demonstrated ability to maintain professionalism in academic/research environments.
- Demonstrated reliability in attendance and punctuality in an academic/research setting
- Ability to provide 2-3 strong professional references
Preferred Qualifications:
- Familiarity with neurological disorders and understand a wide variety of neurological testing procedures.
- Prior academic or professional exposure to patient care and clinical research.
- Fluency in the usage of 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 to what is realistic and appropriate for patient participation.
- Experience with electronic medical records.
- Bachelor’s degree in a related field or equivalent experience.
- 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
Equal Employment Opportunity: The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
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