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NCIRE - The Northern California Institute for Research and Education, Inc. · 4 months ago

Staff Research Associate II (Clinical Research Coordinator)

San Francisco, CA

Part-time

Onsite

Mid, Senior Level, Lead/Staff

$25.24/hr - $40.60/hr

NCIRE - The Northern California Institute for Research and Education, Inc. is seeking a Clinical Research Coordinator II to provide clinical and administrative support for various research studies in the SFVAHCS Cardiac Catheterization Laboratory. The role involves coordinating clinical studies, ensuring compliance with protocols and regulations, and collaborating with research teams to maintain data quality and participant engagement.

BiotechnologyHealth CareMedicalNon Profit

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 according to Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) procedures

Responsible for screening subjects to evaluate subjects' records to determine eligibility according to the protocol's criteria. Pl is responsible for final eligibility approval

As delegated by the Investigator, conducts the informed consent process and ensure all aspects of the process are met. Document the consent process according to. SFVAMC research policies

Collects clinical data required by the study protocol. Maintain complete and accurate case report forms and source documentation for each subject enrolled. Correct data discrepancies/inconsistencies identified in a timely manner

Documents all significant study patient encounters in EMR, including appropriate clinical assessment and plan under supervision of PI and/or Research Nurse, ensuring the PI and/or Research Nurse is kept informed of all encounters and including the PI and Research Nurse as a co-signer on progress notes

Communication of all protocol-related issues/problems to the PI, Research Nurse and the sponsor. Report serious adverse events promptly according to the protocol requirements and local IRB and SFVAMC R&D policies

Help to ensures that Study Drug or Device administration is completed per protocol. Maintain complete and accurate records of the receipt, dispensing, retrieval and return of Study Drug or Device

Coordinates and participates in meetings, conferences, training sessions and other forums regarding the conduct of the clinical study, including national PI/ Study Coordinator meetings requiring travel. Identify any barriers regarding recruitment, enrollment, and any other issues involving study activities

Contribute to the preparation and participates in quality assurance activities (monitoring visits, internal not for cause audits and sponsor audits)

Ensure that all VA sensitive information is being used, stored and secured in accordance with the VHA policies and guidance

Maintains files documenting research trainings, credentials, research-related TMS certificates, CVs, licensing, certifications, memberships, and other related materials for each study team member and gives timely reminders and assistance as needed to maintain these and prevent expiration and provides evidence to sponsors and others requiring it

Scheduling of study sessions, meetings, phone calls, etc

Screen potential study participants, obtain informed consent from study participants, explain study procedures to participants, and run study participants in IRB-approved studies

Maintaining reliable and regular contact with faculty, and keep PI apprised of study updates

Performs other related duties as assigned

Qualification

Clinical research coordinationGCP guidelines knowledgePhlebotomy experienceIATA certificationIRB regulations knowledgeHIPAA regulations experienceAnalytical skillsMicrosoft Office proficiencyProject management skillsCommunication skillsInterpersonal skillsAttention to detail

Required

Minimum Bachelor of Science and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities

Previous experience in coordinating and conducting clinical research studies. Preference for conducting Cardiac Catheterization Laboratory clinical trials or similar experience

Knowledge of the code of federal regulations 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 (1) month of hire

Willingness to learn IRB / SFVAMC R&D regulations and reporting requirements

Experience with study documentation and HIPAA regulations

Experience working with diverse teams of interdisciplinary administrators and clinicians with ease and professionalism to effectively coordinate study activities. Maintain professional conduct in the presence of subjects, clinical staff and sponsors

Ability to conduct and manage multiple projects, tasks and priorities to achieve desired goals

Required to have and maintain documentation of annual training in ethics of human subject research and GCPs

Ability to work under minimal supervision and meet deadlines

Strong accuracy and attention to detail with general project management

Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team

Proficiency with Microsoft Word, PowerPoint, and Windows

Excellent analytical and problem-solving skills

Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects

Ability to establish cooperative working relationships with patients, co-workers, and physicians