PURPOSE:

To coordinate a variety of complex activities and perform duties and procedures related to the start-up, conduct and close-out phases of clinical pharmaceutical and device research protocols. To obtain clean, objective, and accurate data within sponsor timelines while following applicable company SOPs, policies and procedures, federal regulations, medical ethics, Good Clinical Practices (GCPs), International Council of Harmonization (ICH), Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. All responsibilities should be completed in accordance with the companies Core Values, Mission Statement and Employee Manual.

ESSENTIAL JOB FUNCTIONS:

• Read, understand, and can accomplish protocol specified patient visits and procedures.
• Clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs.
• Obtain patient informed consent according to federal regulations, GCPs and IRB requirements.
• Is creative and diligent in recruiting qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines.
• Complete all required training in a timely manner.
• Schedule and conduct patient visits according to protocol requirements and timelines.
• Maintain accurate and complete written source documentation of patient visits and protocol related activities.
• Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets generated by the sponsor.
• Maintain confidentiality of patient and protocol issues as appropriate and as bound by Confidentiality Agreements with company, between company and sponsors, and between company and other entities, as well as HIPAA regulations.
• Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.
• Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to the supervisor, Principal Investigator and/or Sub-Investigator.
• Account for clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study.
• Maintain ongoing communication with team manager; Principal Investigator; Sub-Investigators and other persons assisting with the trial and document these communications according to protocol requirements and company policies.
• Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and company policies.
• Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
• Attend Investigator Meetings and/or other trainings as directed.
• Perform all study-related duties in a time- and cost-effective manner in adherence with company policies.
• Represent the company in a professional and courteous manner (verbal, written and in appearance) when interacting with company staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals, and physician’s offices.
• Additional duties as assigned by management.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

• Work is normally performed in a typical interior/office work environment.
• Travel may be required for conferences and/or training.
• Exposure to human bodily fluids.
• Laboratory processing procedures.
• Subject/Patient care.
• Daily computer use.
• Occasional night and weekend work schedules depending on study requirements.
• The ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
• Ability to drive, and daily availability of an automobile.

MINIMUM REQUIREMENTS:

Education: Bachelor's degree preferred; however, is not required.

Experience: Preferably a minimum of 3 years’ experience as a CRC, plus 5+ years' minimum experience within the field of clinical research or biological research. Some sort of management experience preferred.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

^*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.