Clinical Research Coordinator II

** This is a West Los Angeles, In-Person, Position. Local Applicants Only Please **

Company Description

BNL Health Inc is a comprehensive neurology practice offering both clinical and research services. With locations in Century City and Torrance, CA, the organization is dedicated to providing exceptional patient care and advancing neurological research. BNL Health Inc fosters innovation and collaboration, aiming to enhance the treatment and understanding of neurological conditions. Professionals at BNL Health Inc are valued contributors to both clinical excellence and groundbreaking studies.

Role Description

The Clinical Research Coordinator II (CRC II) will be responsible for the coordination and administration of multiple research studies. Serves as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Responsible for recruiting, screening, consenting, and enrolling patients in clinical trials. CRC II also coordinates and oversees the subject’s visits in accordance with the protocol requirements.

Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers. Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department. Trains new staff. Develops procedures related to clinical trial coordination.

Acts as resource for the education and training of clinic staff as well as resource for problem solving complex issues for the implementation of the research process throughout the clinic, process improvements and SOPs. Compiles and reports protocol activity; accrual data, and financial information. Interacts with study participants diagnosed with various medical conditions and diagnoses.

Responsible for data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports. Assures site research quality by practicing in compliance with BNL Health, Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Works closely with Principal Investigators, the Research Staff, and the Clinical Staff, facilitating all aspects of assigned clinical trials. Must uphold the standards of confidentiality, attendance, and punctuality. Performs all duties in a manner which promotes team concept.

Primary Duties and Responsibilities 

• Serve as the primary contact to ensure appropriate communications, trial management, and meeting of timelines.

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, participating in the informed consent process, and scheduling patients for research visits and procedures.

• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug, drug accountability, and protocol deviations.

• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.

• Ensure the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance.

• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.

• Assure ongoing compliance with all system, regulatory, federal regulations, and department policies. Support & assist in all aspects of clinical data management, including creation, and collection of source documents, online clinical trials electronic data capture databases (e.g. Veeva, RedCap), completion of case report forms, and tracking/reporting of serious adverse events. Collects and maintains complete records and statistics on each research study patient.

• Support and assist in the preparation of study documents such as study operating procedures manual, monitoring manual, laboratory manual, study protocols, informed consent and recruitment materials.

• Assist with the submission of regulatory documents in accordance with IRB, federal, industry, and institutional guidelines and requirements.

• Coordinate the collection and processing of biospecimens for research projects and clinical trials conducted within BNL Health. Arranges for review and submission of pathology materials and/or radiology materials as required per protocol

• Assist with and/ or oversees study activities including training other clinical trial support staff and assuring quality assurance of study activities and quality data. Provide current and accurate protocol resources to investigators and staff.

• Attend investigators meetings/ various study related training and meetings.

• Liaise with sponsors when applicable and coordinate study drug shipments and accountability. Set-up monitoring visits and addresses monitoring reports where applicable

• Assist with quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate

• Demonstrated proficiency organizing and maintaining study data within an electronic Clinical Trial Management System (CTMS), such as CRIO, Medidata Rave.

• Must be able to travel between sites in Century City, CA and Torrance, CA on a regular basis to manage site activities

• Must have a valid driver’s license

These job duties listed are essential functions of the position. However, other duties may be assigned, and may also be considered essential functions of the position.

Education

Bachelor's Degree or equivalent education/ experience preferably in a scientific or health-related field, nursing qualification or relevant experience and have clinical research monitoring experience (including interim monitoring and closeout visits).

Work Experience

• > 3 Years: Demonstrated clinical research experience, specifically in research project coordination (project management), medical terminology, data entry, biospecimen registry, and clinical trial operations (International Council of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) Guidelines, regulatory requirements)
• > 3 Years: Full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• > 3 Years: Experience with Electronic Data Capture Systems (Veeva Vault EDC, InForm, Medidata Rave EDC, RedCap) and CTMS (CRIO, Veeva Vault CTMS, Medidata Rave CTMS, Advarra Clinical Conductor, Oracle Siebel)
• > 2 Years (Preferred): Brain-health related research