• Ensures that clinical trials are conducted according to protocol requirements by utilizing multiple techniques and procedures
• Collects and processes biological samples for assay, storage and shipment
• Records volunteer adverse events with referral to medical or nursing personnel for evaluation and treatment
• Performs electronic and diagnostic measurements including Audiograms, Electrocardiograms
• Visual exams and other novel devices
• Performs and records physical measurements including vital signs, body measurements and pupillometry
• Assists in the development of new testing procedures
• Collects, measures, and processes human biological samples for lab analysis
• Generates computer labels for lab and drug assay samples
• Process volunteer identification (photos and badges) and provide necessary instruction to research participants

Skills: Clinical Trial Protocol Adherence, Biological Sample Collection and Processing, Adverse Event Documentation and Referral, Diagnostic Measurements, Physical Measurement Recording, Development of Testing Procedures, Label Generation and Sample Handling, Volunteer Identification and Instructions

• Provides superior service to principal investigators and research sponsors within the scope of responsibilities.
• Primarily focus on data entry, patient follow-up visits and phone calls.
• Coordinates multiple aspects of clinical trials and other human research ensuring compliance with research protocol and IRB requirements.
• Complete case report forms and conduct surveys on study participants
• Organize and maintain clinical information and records that may be related to multiple studies.
• Assist with data processing and collect, organize and maintain data in an electronic database.
• Assist with participant recruitment and accompany participants
• Assist with maintaining study protocol documents and IRB compliance.
• Communication with the Institutional Review Board (IRB).
• Assists in the clinic kitchen, including ordering and serving scheduled meals
• Interact as a point of contact for various external services/representatives (manufacture representatives and laundry/supplies personnel)
• Order and maintain daily lab supplies and maintain equipment log and calibration records

Skills: Clinical Data Management, Patient Coordination, Regulatory Compliance, Communication Skills, Organizational Skills, Survey and Report Completion, Administrative Support, Technical Assistance

• Assist in the start-up of new clinical studies, working directly with a study team to generate, distribute and obtain required study documents.
• Assist in the set-up and maintenance of the central filing system to ensure complete, accurate and current files of regulatory documents and study records.
• Maintain and track study site clinical supplies (drugs, devices, etc.) and associated documentation.
• Assist staff in the preparation and implementation of investigator meetings.
• Develop and maintain communication with internal and external departments/offices.
• Responsible for the production and distribution of clinical meeting agendas and meeting minutes.
• Set up new studies in the Clinical Trial Management System (CTMS) and track regulatory documents, CRFs and data queries within CTMS.
• Assist CRAs in preparing for study closeout by conducting TMF reviews and compiling closeout binders.
• Archive TMF and related project files for completed studies.
• Develop a knowledge of therapeutic areas associated with clinical studies through journals, seminars, review of clinical protocols, synopses etc.
• Develop an understanding of the procedures and standards associated with the conduct of clinical studies including a thorough knowledge of GCPs, ICH and other regulatory guidelines.

Skills: Clinical Study Start-Up Support, Central Filing System Management, Clinical Supplies Tracking, Investigator Meeting Preparation, Cross-Departmental Communication, Meeting Documentation, Clinical Trial Management System (CTMS) Proficiency, Trial Master File (TMF) Management

• Maintains current and accurate protocol documentation and notifies appropriate individuals of pertinent protocol changes.
• Identifies and communicates important protocol and data management issues to appropriate individuals.
• Verifies that patients have completed appropriate registration materials and maintains related records and information.
• Instructs volunteers on protocol requirements and explains procedures and consent forms.
• Ensures related documentation is properly completed.
• Ensures protocol compliance with intense monitoring of specific study requirements and schedules protocol-related treatment and tests.
• Performs specific clinical duties per the research study.
• Assists in ordering and maintaining research supplies
• Prepares and maintains a variety of documentation in assigned areas of responsibility.
• May serve as a backup, collecting and delivering specimens for analysis using appropriate or specified equipment.
• Ensures proper labeling and obtains pertinent clinical and protocol information on request forms.
• Department-level responsibility and some research of references using the library or internet

Skills: Protocol Documentation Management, Issue Identification and Communication, Patient Registration and Record Keeping, Volunteer Instruction and Consent, Compliance Monitoring, Clinical Duties Execution, Research Supply Management, Documentation and Specimen Handling

• Supervision of site activation and site management including monitoring activities (from feasibility to close out) by relevant parts of GCP/GPP/GEP, SOPs, the study protocol and study plan in national and international clinical trials / non-interventional studies
• Training of CRAs /Clinical Trial Assistants (CTAs) on study-specific requirements
• Development of project-specific training material for CRAs and study sites
• Project-specific review of timelines and client’s requirements regarding site management and monitoring activities
• Identification of critical issues at an early stage and escalation Management
• Support of review of Standard Operating Procedures (SOPs) and engagement in process improvement initiatives
• Contribution to or preparation of submissions and/or notifications to the Ethics Committees (EC) and to the Regulatory Authorities (RA)
• Development and review of the Monitoring / Quality Review Plan
• Contribution to the initial set-up, ongoing maintenance and final distribution of the Study/ Trial Master File
• Preparation of the Investigator Site File and coordination of its distribution and ongoing maintenance of the respective sections of the Study/Trial Master File
• Coordination and review of monitoring reports and Follow-up communication
• Have frequent interaction with patients, families, visitors, physicians, and related clinical departments.
• Assist in the preparation of weekly team meeting project management updates.

Skills: Clinical Trial Management, Training and Development, Project Management, Issue Identification and Escalation, SOP Review and Process Improvement, Regulatory Submissions, Document Management, Communication and Coordination

• Ability to analyze complex or diverse information
• Ability to collect and research data
• Can use results, intuition, and experience to synthesize product-specific direction.
• Ability to generate creative solutions and demonstrate attention to detail.
• Gathers and analyzes information skillfully
• Ability to develop alternative solutions and work well in group problem-solving situations.
• Can speak clearly and persuasively in positive or negative situations
• Can listen gets clarification and responds clearly to questions.
• Able to write clearly, informative, and present numerical data effectively
• Able to read and interpret medical, scientific and engineering literature.
• Ability to support the organization's goals and values.
• Adapts to changes in the work environment and manages competing demands

Qualifications: BS in Clinical Research with 5 years of Experience

• Have Clinical Research Experience
• Interpersonal and communication skills, interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
• Knowledge of medical terminology and laboratory skills 
• Accuracy, attention to detail, and ability to set priorities and meet deadlines
• Knowledge of Microsoft Office and knowledge of local country regulations( FDA etc.)
• Adapts to changes in approach or method to best fit the situation
• Able to deal with frequent changes, delays, or unexpected events. 
• Displays original thinking and creativity; meets challenges with resourcefulness
• Ability to generate suggestions for improving work and develop innovative approaches and ideas.
• Able to set and achieve challenging goals
• Demonstrates persistence and overcomes obstacles
• Must have relevant experience in supporting clinical programs for medical devices including clinical trials.

Qualifications: BS in Biochemistry with 6 years of Experience

• Prior experience in research
• Proficient with Microsoft Office Suite, specifically Excel
• Excellent written and verbal communication skills.
• Ability to multitask, prioritize and manage time efficiently.
• Ability to work in a team setting as well as independently.
• Enjoy interacting with a diverse group of people with an ability to listen and provide empathy
• Self-directed and able to work without supervision.
• Previous health care experience.
• Good working knowledge of Windows computer systems.
• Strong oral and written communication skills.
• Excellent critical thinking and problem-solving skills.

Qualifications: BS in Nursing with 2 years of Experience

• Have college-level coursework in biological or life sciences or health-related field
• Experience in a research or healthcare setting
• Familiarity with US Food & Drug Administration (FDA) regulations and the International Conference on
• Harmonization (ICH) and Good Clinical Practice (GCP) guidelines
• Knowledge of medical terminology
• Proficiency in Microsoft Office applications (Outlook, Word, Excel and PowerPoint).
• Familiarity with electronic data capture (EDC) systems preferred (e.g. REDCap and StudyTrax).
• Intermediate knowledge of medical terminology.
• Certifications in the Protection of Human Subjects and Good Clinical Practice, per institutional and regulatory guidelines.
• Excellent organizational skills and an ability to effectively manage time and prioritize workload.
• Ability to build rapport and interact effectively with a broad array of people from diverse cultural and educational backgrounds.

Qualifications: BS in Biology with 3 years of Experience

• Ability to answer incoming calls and take appropriate and detailed messages
• Ability to file accurately in both alphabetical and numerical sequence
• Ability to work in a fast-paced environment and to shift priorities to meet deadlines
• Skills in performing duties with frequent interruptions and/or distractions
• Willingness to travel between UCLA Westwood and Santa Monica Clinic
• Ability to compose correspondence, prepare logs, and complete research forms/documents using clear and concise English grammar
• Ability to work with a high level of accuracy especially when preparing lab specimens for shipment and/or delivery to clinical research laboratories
• Facility with medical terminology and a strong understanding of the delivery of medical care.
• Analytical skills are necessary to accurately interpret and implement complex policy.
• Comfortable working both independently and as part of a team.
• A high degree of professionalism, discretion, and confidentiality

Qualifications: BS in Health Sciences with 7 years of Experience