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, Associate Project Director, 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 Clinical Research Coordinator will independently execute, manage, and coordinate multiple clinical research protocols within the MACS/WIHS Combined Cohort Study (MWCCS) - a collaborative, multi-center, longitudinal study designed to comprehensively investigate the impact of chronic health conditions that affect people with HIV. CRC duties may include, but will not be limited to recruiting and screening new enrollees, supporting the management and coordinating the tasks of multiple concurrent clinical research studies; act as intermediary between services and departments while overseeing data and specimen collection; clean and update, databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of new CRCs; may assist with management of Investigator's protocols in the Investigational Review Board online system, as well as renewals and modifications of protocol applications and the implementation of new studies; 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.

Study Coordination and Data Collection/ Essential/ 55%

• Identify subjects, develop recruitment and retention strategies,and screen and enroll study subjects.

• Schedule subjects for study visits, including coordinating transportation logistics;

• Meet with study participants to administer questionnaires, collect medical history and perform study procedures (i.e. blood pressure measurement, anthropometrics, physical function assessments, biospecimen collection (urine, hair and oral specimen, and other study protocol procedures, per training)

• Phlebotomy, perform venipunctures to collect blood, per protocol.

• 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.

• Collect, conduct reviews of, and redact medical charts and electronic records to extract medical information and other data for use in studies.

• Coordinate data reporting with participants and their providers, per protocol; including, but not limited to, lab results, Fibroscan results and other substudy results after review by study clinician.

• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.

• Independently schedule and complete additional study and sub-study visits to obtain additional study aspects beyond the Core visit (e.g. Pulmonary function tests (PFT), mental health questionnaires (CIDI), focus groups, etc)

Data management and reporting of results/Essential/15%

* Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into study 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 Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.

Staff training/Essential/5%

• 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

Quality control procedures/Essemtial/5%

• 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

Study Implementation/Essential/5%

• Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.

• Modify data collection instruments

• Maintain subject tracking systems.

Specimen Management/ Maintenance/Essential/5%

• 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.

Protocol Submissions and Adherence/Essential/5%

• Enter new study protocols into the Investigational Review Board (iRIS) online system; seek assistance on maintaining all protocols in the system by communicating with IRB Analysts.

• Design and enhance case report forms and data collection forms as needed, with supervisory guidance; 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 IRB applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between IRB and study Investigators.

• Provide quality assurance checks to note if protocols or UCSF IRB applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.

Regulatory responsibilities/Essential/5%

• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.

• Initiate and follow-up on IRB 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.

Required Qualifications

• College graduation, with BA/BS and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• 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.
• Sufficient phlebotomy skills to achieve successful biospecimen collection in study visits.
• California Certified Phlebotomist (CPT-1)

Preferred Qualifications

• Minimum of 1 years of related research or work experience in public health, epidemiology, health promotion, social sciences, or related field or an equivalent combination of education and experience.
• Spanish speaker, fluency in reading, writing and speaking Spanish, with the ability to accurately obtain informed consent and administer Spanish translated forms.
• Demonstrated history of excellent attendance, reliability, and dependability.
• Previous experience in HIV-related clinical research and the ability to adhere to structured protocols.
• Fluency in the usage of Investigational Review Board (IRB) online iRIS system for submission, renewal, and modification of protocols through this system.
• Understanding of patient population (e.g. HIV, drug users, mental health challenges) to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• Experience with electronic medical records.
• 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: SalesForce,
• 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
  

Required Qualifications

• College graduation, with BA/BS and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• 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.
• Sufficient phlebotomy skills to achieve successful biospecimen collection in study visits.
• California Certified Phlebotomist (CPT-1)

Preferred Qualifications

• Minimum of 1 years of related research or work experience in public health, epidemiology, health promotion, social sciences, or related field or an equivalent combination of education and experience.
• Spanish speaker, fluency in reading, writing and speaking Spanish, with the ability to accurately obtain informed consent and administer Spanish translated forms.
• Demonstrated history of excellent attendance, reliability, and dependability.
• Previous experience in HIV-related clinical research and the ability to adhere to structured protocols.
• Fluency in the usage of Investigational Review Board (IRB) online iRIS system for submission, renewal, and modification of protocols through this system.
• Understanding of patient population (e.g. HIV, drug users, mental health challenges) to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• Experience with electronic medical records.
• 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: SalesForce,
• 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