NCIRE - The Northern California Institute for Research and Education, Inc.
Staff Research Associate II (Clinical Research Coordinator)
NCIRE - The Northern California Institute for Research and Education, Inc., San Francisco, California, United States, 94199
Overview
Staff Research Associate II (Clinical Research Coordinator) will provide clinical and administrative support to the Principal Investigator for research studies conducted in the SFVAHCS Cardiac Catheterization Laboratory (CCL). The incumbent must be able to work on-site at the SFVAHCS. Responsible for performing clinical research activities as delegated by the PI and Research Nurse within appropriate scope of practice, ensuring conduct of study activities according to protocols, governmental regulations, GCP guidelines and local site SOPs. Responsibilities
Contributes to planning and organizing the clinical aspects of the research studies. Identify and coordinate with interdisciplinary departments involved with the implementation of the clinical study. Assist with providing in-services and support as needed for personnel involved with the care of subjects and research activities. Aid in the preparation and management of IRB submissions and reports. Maintain regulatory documents in compliance with SOPs and Good Clinical Practice (GCP) procedures. Screen subjects to evaluate records for eligibility according to protocol criteria. Assist with final eligibility determination. Conduct the informed consent process as delegated by the Investigator and document consent according to SFVAMC research policies. Collect clinical data required by the study protocol; maintain complete and accurate case report forms and source documentation; correct data discrepancies in a timely manner. Document significant study patient encounters in EMR under supervision of PI and/or Research Nurse; keep the PI and Research Nurse informed of all encounters and co-sign progress notes as needed. Communicate protocol-related issues/problems to the PI, Research Nurse and sponsor; report serious adverse events promptly per protocol requirements and local policies. Ensure Study Drug or Device administration is completed per protocol; maintain records of receipt, dispensing, retrieval and return of study materials. Coordinate and participate in meetings, conferences, training sessions and other forums; assist with identifying barriers to recruitment and study activity as needed. Participate in quality assurance activities (monitoring visits, audits) and ensure compliance with VA policies and guidance on data handling and security. Maintain files documenting research trainings, credentials, certificates, licenses, and memberships for the study team; provide reminders to maintain compliance. Schedule study sessions, meetings, phone calls, etc.; maintain reliable and regular contact with faculty and keep PI apprised of updates. Screen potential study participants, obtain informed consent, explain procedures, and enroll participants in IRB-approved studies. Qualifications
Minimum Bachelor of Science and demonstrated experience to perform the duties Experience coordinating and conducting clinical research studies; preference for Cardiac Catheterization Laboratory trials or similar experience Knowledge of CFRs for conducting clinical research, GCP guidelines and SOPs Prior extensive experience with phlebotomy, specimen collection, processing and shipping IATA certification or willingness to obtain within one month of hire Willingness to learn IRB/SFVAMC R&D regulations and reporting requirements Experience with study documentation and HIPAA regulations Ability to work with diverse teams; maintain professionalism with subjects, staff and sponsors Ability to manage multiple projects and priorities; meet deadlines Documentation of annual training in ethics of human subject research and GCPs Ability to work under minimal supervision; strong attention to detail and project management Excellent verbal and written communication, organizational and interpersonal skills Proficiency with Microsoft Word, PowerPoint, and Windows; strong analytical and problem-solving skills Ability to work effectively in a fast-paced, team-based environment and coordinate study activities Ability to establish cooperative working relationships with patients and staff Working Conditions
The work environment includes an indoor office and a medical research setting. Possible variations in noise and temperature; prolonged computer use; standing or seated work as needed. Onboarding and Compliance
NCIRE is affiliated with the San Francisco VA Health Care System (SFVAHCS) and requires completion of SFVA onboarding in addition to NCIRE onboarding. SFVA requires a federal background check, occupational health clearance, vaccines and immunizations, and drug testing for certain positions. Drug testing may include marijuana, which is illegal under federal law; failing drug tests will disqualify candidates. Salary
The base salary range is $25.24 - $40.60 per hour. Offered salary will consider factors including location, experience, knowledge, education, and internal equity. A successful candidate may be eligible for additional compensation including bonuses. Note: The Northern California Institute for Research and Education (NCIRE) is an Equal Employment Opportunity Employer. NCIRE provides equal opportunity to all employees and applicants regardless of race, color, sex, religion, national origin, ancestry, age, marital status, medical condition, disability, veteran status, sexual orientation, or other protected characteristics; employment decisions are based on merit and qualifications.
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Staff Research Associate II (Clinical Research Coordinator) will provide clinical and administrative support to the Principal Investigator for research studies conducted in the SFVAHCS Cardiac Catheterization Laboratory (CCL). The incumbent must be able to work on-site at the SFVAHCS. Responsible for performing clinical research activities as delegated by the PI and Research Nurse within appropriate scope of practice, ensuring conduct of study activities according to protocols, governmental regulations, GCP guidelines and local site SOPs. Responsibilities
Contributes to planning and organizing the clinical aspects of the research studies. Identify and coordinate with interdisciplinary departments involved with the implementation of the clinical study. Assist with providing in-services and support as needed for personnel involved with the care of subjects and research activities. Aid in the preparation and management of IRB submissions and reports. Maintain regulatory documents in compliance with SOPs and Good Clinical Practice (GCP) procedures. Screen subjects to evaluate records for eligibility according to protocol criteria. Assist with final eligibility determination. Conduct the informed consent process as delegated by the Investigator and document consent according to SFVAMC research policies. Collect clinical data required by the study protocol; maintain complete and accurate case report forms and source documentation; correct data discrepancies in a timely manner. Document significant study patient encounters in EMR under supervision of PI and/or Research Nurse; keep the PI and Research Nurse informed of all encounters and co-sign progress notes as needed. Communicate protocol-related issues/problems to the PI, Research Nurse and sponsor; report serious adverse events promptly per protocol requirements and local policies. Ensure Study Drug or Device administration is completed per protocol; maintain records of receipt, dispensing, retrieval and return of study materials. Coordinate and participate in meetings, conferences, training sessions and other forums; assist with identifying barriers to recruitment and study activity as needed. Participate in quality assurance activities (monitoring visits, audits) and ensure compliance with VA policies and guidance on data handling and security. Maintain files documenting research trainings, credentials, certificates, licenses, and memberships for the study team; provide reminders to maintain compliance. Schedule study sessions, meetings, phone calls, etc.; maintain reliable and regular contact with faculty and keep PI apprised of updates. Screen potential study participants, obtain informed consent, explain procedures, and enroll participants in IRB-approved studies. Qualifications
Minimum Bachelor of Science and demonstrated experience to perform the duties Experience coordinating and conducting clinical research studies; preference for Cardiac Catheterization Laboratory trials or similar experience Knowledge of CFRs for conducting clinical research, GCP guidelines and SOPs Prior extensive experience with phlebotomy, specimen collection, processing and shipping IATA certification or willingness to obtain within one month of hire Willingness to learn IRB/SFVAMC R&D regulations and reporting requirements Experience with study documentation and HIPAA regulations Ability to work with diverse teams; maintain professionalism with subjects, staff and sponsors Ability to manage multiple projects and priorities; meet deadlines Documentation of annual training in ethics of human subject research and GCPs Ability to work under minimal supervision; strong attention to detail and project management Excellent verbal and written communication, organizational and interpersonal skills Proficiency with Microsoft Word, PowerPoint, and Windows; strong analytical and problem-solving skills Ability to work effectively in a fast-paced, team-based environment and coordinate study activities Ability to establish cooperative working relationships with patients and staff Working Conditions
The work environment includes an indoor office and a medical research setting. Possible variations in noise and temperature; prolonged computer use; standing or seated work as needed. Onboarding and Compliance
NCIRE is affiliated with the San Francisco VA Health Care System (SFVAHCS) and requires completion of SFVA onboarding in addition to NCIRE onboarding. SFVA requires a federal background check, occupational health clearance, vaccines and immunizations, and drug testing for certain positions. Drug testing may include marijuana, which is illegal under federal law; failing drug tests will disqualify candidates. Salary
The base salary range is $25.24 - $40.60 per hour. Offered salary will consider factors including location, experience, knowledge, education, and internal equity. A successful candidate may be eligible for additional compensation including bonuses. Note: The Northern California Institute for Research and Education (NCIRE) is an Equal Employment Opportunity Employer. NCIRE provides equal opportunity to all employees and applicants regardless of race, color, sex, religion, national origin, ancestry, age, marital status, medical condition, disability, veteran status, sexual orientation, or other protected characteristics; employment decisions are based on merit and qualifications.
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