Senior Clinical Research Coordinator

Essential Job Functions

• Read, understand, and 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
• Recruit 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 Flourish Research, between Flourish and sponsors, and between Flourish 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 Lead I; Team Manager; Principal Investigator; Sub-Investigators and other people assisting with the trial and documenting these communications according to protocol requirements and Flourish policies
• Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and Flourish 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 Flourish policies
• Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with Flourish 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 required
• Exposure to human bodily fluids
• Laboratory processing procedures
• Subject/Patient care
• Daily computer use
• Occasional night and weekend work schedules
• The ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds
• The 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.

Knowledge and Skills

• 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 to include Office365 products
• Experience in 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
• Flexible and able to multi-task and prioritize competing demands
• Ability to think independently and influence when appropriate
• Develops and implements key initiatives in the department
• Identifies and implements process improvements for increased efficiency
• Builds and fosters relationships across teams
• Consistently accomplishes 80% of individual rocks
• Serves as preceptor, mentor and subject matter expert in department
• Demonstrates strong critical thinking and decision-making skills
• Continually demonstrates core values and is regarded as a leader
• High proficiency of skills set
• Must have industry certification, as applicable by Flourish Research