Highland Performance Solutions is proud to be leading a retained search for Flourish Research for a Clinical Research Coordinator at the de novo site in Little Haiti, FL. This role is onsite and requires language proficiency in Haitian Creole.
Who We Are
Advancing the health and wellness of society through clinical trials, Flourish Research is one of the largest integrated clinical research site companies in the US, with best-in-class sites who have a strong brand and track-record of recruiting and retaining a highly diversified patient populations in the therapeutic areas of cardiology, metabolic disorders/renal, CNS, pulmonology, and vaccines. Flourish’s fully integrated site network strategy with centralized infrastructure and investment in technology allows for superior patient access, engagement, and diversification as well as consistent, high quality data delivery. Flourish has differentiated its sites through an investment in Quality Management Systems, a focus on patient diversity, and deep clinical expertise backed by SMEs in its Centers of Excellence focus areas.
The Role & Opportunity
As a Clinical Research Coordinator, you will 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 Flourish 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 Flourish Research’s Core Values, Mission Statement and Employee Manual. This role reports to the Site Director.
Key Responsibilities
- 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 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 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 Clinical Team Manager, Principal Investigator, Sub- Investigators and other persons assisting with the trial and documenting these communications according to protocol requirements and Flourish policies.
- Attend required training courses/conferences 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.
- Perform all duties in a safe and prudent manner.
- Perform other duties as assigned.
- 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.
- Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
- Ability to drive, and daily availability of an automobile.
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.
Minimum Requirements
- Fluency in Haitian Creole is a requirement for this position.Bachelor's degree preferred; however, is not required.
- Preferably a minimum of 2 years’ experience as a CRC, plus 1-3+ years' minimum experience within the field of clinical research or biological research.
- Given this is a start-up site, the CRC is fully responsible for consenting patients, taking vitals, performing ECGs, and other trial-related duties.
- The ability to perform phlebotomy and conduct laboratory processing procedures is required.
Compensation and Benefits Package
- $55,000 - $65,000 a year. This position is paid hourly.Paid Time Off
- 8 Paid holidays, Including 2 Floating Holidays
- 401K plan: 4% Match
- Employee Review and Performance Program
- Tuition Reimbursement Policy
- Employee Referral Bonus
- Supplemental Parental Leave
Why Join Flourish Research?
- Be part of a mission-driven organization dedicated to advancing clinical research.
- Opportunity to lead and grow a start-up site with significant impact.
- Collaborative and supportive work environment.
Requirements for Application
- Apply via LinkedIn or send a resume and salary requirements to: executivesearch@highlandperformancesolutions.com
- No faxes or phone calls will be accepted
- Flourish is an equal opportunity employer
