Clinical Research Coordinator

Flourish Research•Northridge, CA

26d•Onsite

About The Position

Flourish Research is hiring a Clinical Research Coordinator to support its onsite Northridge, California site. The role supports clinical trials across areas including cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. The position is classified as non-exempt and pays $30–$33 per hour, depending on experience. The stated schedule is Monday through Friday, day shift, 40 hours per week; occasional night and weekend work may also be required. The coordinator conducts protocol-specified patient visits and procedures, documents study information in accordance with regulations and protocol requirements, obtains informed consent, recruits and schedules participants, and completes source documentation and sponsor forms. The role also involves maintaining confidentiality, reporting adverse events and serious adverse events, accounting for clinical trial materials, communicating with study personnel, completing required training, and representing Flourish Research professionally. Work is normally performed in an interior office environment and includes travel, laboratory processing, patient care, exposure to human bodily fluids, and daily computer use.

Requirements

Bachelor's degree preferred but not required.
Preferably at least 2 years of experience as a Clinical Research Coordinator, plus 1–3 or more years of experience in clinical research or biological research.
Exceptional knowledge of clinical research methods.
Strong management and leadership skills.
Demonstrated ability to collaborate and align with operations.
Excellent oral and written communication skills.
Excellent computer skills, including Office 365 products.
Experience writing and reviewing Standard Operating Procedures.
Strong problem-solving, risk-assessment, and impact-analysis abilities.
Demonstrated experience in process improvement.
Strong negotiation and conflict-management skills.
Ability to multitask and prioritize competing demands.
Ability to think independently and influence when appropriate.
Ability to drive and daily availability of an automobile.
Ability to properly lift 35 pounds and occasionally more than 35 pounds.

Nice To Haves

Bachelor's degree.
At least 2 years of experience as a Clinical Research Coordinator.
At least 1–3 or more years of experience in clinical research or biological research.

Responsibilities

Read, understand, and carry out protocol-specified patient visits and procedures.
Document patient assessments, observations, test results, and other study information according to federal regulations, protocol requirements, and GCPs.
Obtain informed consent in accordance with federal regulations, GCPs, and IRB requirements.
Recruit qualified study participants to meet enrollment obligations within sponsor timelines while following applicable medical ethics, IRB, GCP, and ICH requirements.
Complete 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.
Complete sponsor-generated case report forms, electronic case report forms, and worksheets accurately.
Maintain confidentiality of patient and protocol information in accordance with applicable confidentiality agreements and HIPAA regulations.
Promptly report adverse events to a supervisor and/or Principal Investigator or Sub-Investigator as appropriate.
Report serious adverse events to the sponsor within 24 hours of becoming aware of them, and notify the supervisor and/or Principal Investigator or Sub-Investigator.
Account for clinical trial materials and ensure appropriate quantities are available for study conduct.
Maintain and document ongoing communication with the Team Lead I, Team Manager, Principal Investigator, Sub-Investigators, and others assisting with trials, as required by protocols and company policies.
Attend required training courses and conferences to remain current on regulations and company policies.
Pursue educational opportunities to increase knowledge of clinical research and relevant rules and regulations.
Attend Investigator Meetings and other training as directed.
Perform study-related duties in a time- and cost-effective manner and in adherence with company policies.
Perform duties safely and prudently.
Represent Flourish Research professionally and courteously when interacting with staff, sponsors, IRBs, patients, and medical and nursing staff.
Perform other duties as assigned by management.