Senior Clinical Research Coordinator

Flourish Research•Covina, CA

26d•Onsite

About The Position

Flourish Research is hiring a Senior Clinical Research Coordinator to support its Covina, California site. The role coordinates complex activities and performs duties related to the start-up, conduct, and close-out of clinical pharmaceutical and device research protocols. The coordinator obtains accurate, objective study data within sponsor timelines while following Flourish procedures, federal regulations, medical ethics, Good Clinical Practices (GCPs), International Council of Harmonisation (ICH) guidance, Institutional Review Board (IRB) requirements, and sponsor protocols. The position involves coordinating protocol visits and procedures, obtaining informed consent, recruiting study participants, documenting visits and study activities, completing sponsor case report forms, reporting adverse events, managing trial materials, and communicating with investigators and study teams. The coordinator also completes required training, pursues education in clinical research, supports process improvements, and represents Flourish Research professionally when interacting with staff, sponsors, IRBs, participants, and healthcare personnel. This is an onsite position in Covina, California, with a Monday–Friday day shift and a 40-hour workweek. Travel is required. The work is normally performed in an interior office environment and may involve laboratory processing, patient care, exposure to bodily fluids, daily computer use, and occasional night or weekend schedules. Compensation is $32–$38 per hour, depending on experience.

Requirements

Preferably at least 3 years of experience as a Clinical Research Coordinator, plus at least 5 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 adapt, multitask, and prioritize competing demands.
Ability to think independently and influence when appropriate.
Ability to develop and implement key departmental initiatives and identify process improvements.
Ability to build and foster relationships across teams.
Demonstrated critical-thinking and decision-making skills.
High proficiency in the required skill set and consistent demonstration of Flourish Research core values.
Industry certification, as applicable by Flourish Research.
Ability to lift 35 pounds and occasionally more than 35 pounds.
Ability to drive and daily availability of an automobile.
Willingness and ability to travel.
Bachelor's degree preferred but not required.

Nice To Haves

Bachelor's degree.
At least 3 years of experience as a Clinical Research Coordinator.

Responsibilities

Read, understand, and complete protocol-specified patient visits and procedures.
Document patient assessments, observations, test results, and other study information in accordance with regulations, protocol requirements, and GCPs.
Obtain patient informed consent in accordance with federal regulations, GCPs, and IRB requirements.
Recruit qualified study participants to meet enrollment obligations and sponsor timelines while complying with applicable regulations and ethical requirements.
Complete required training in a timely manner.
Schedule and conduct patient visits according to protocol requirements and timelines.
Maintain accurate and complete source documentation of patient visits and protocol-related activities.
Complete sponsor-generated case report forms (CRFs/eCRFs) and worksheets accurately.
Maintain confidentiality of patient and protocol information in accordance with applicable agreements and HIPAA regulations.
Promptly report adverse events to a supervisor and/or Principal Investigator or Sub-Investigator as necessary.
Report Serious Adverse Events to the sponsor within 24 hours of becoming aware of them, and notify the supervisor and Principal Investigator and/or Sub-Investigator.
Account for clinical trial materials, including CRFs, study drug, laboratory supplies, and other required items, and ensure adequate supplies are available.
Maintain ongoing communication with the Team Lead I, Team Manager, Principal Investigator, Sub-Investigators, and other trial personnel, and document communications as required.
Attend required training courses, conferences, Investigator Meetings, and other trainings as directed.
Pursue educational opportunities to increase knowledge of clinical research and applicable rules and regulations.
Perform study-related duties in a timely and cost-effective manner consistent with Flourish policies.
Represent Flourish Research professionally and courteously when interacting with staff, sponsors, IRBs, patients, and medical and nursing personnel.
Perform additional duties as assigned by management.
Serve as a preceptor, mentor, and departmental subject matter expert.
Develop and implement departmental initiatives and identify and implement process improvements.