Clinical Research Coordinator

Flourish Research; Detroit (MI); Vor Ort; USD 41.000 - 48.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) match

Tuition reimbursement

Generous PTO

Zusammenfassung

Flourish Research in Detroit, IL is seeking a Clinical Research Coordinator to support a busy site. You will coordinate start-up, conduct, and close-out activities across pharmaceutical and device studies, ensuring data quality and sponsor timelines.

You will manage patient visits, consent, data entry, and adverse event reporting, while upholding GCP, IRB, and HIPAA standards. A Bachelor's degree is preferred and CRC experience is valued.

Qualifikationen

• Bachelor’s degree preferred but not required.
• 2 years CRC experience + 1–3+ years in clinical or biological research.
• Strong knowledge of clinical research methods and GCP.

Aufgaben

• Read, understand, and perform protocol visits and procedures.
• Document patient assessments, observations, test results per regulations and GCP.
• Obtain informed consent according to federal regulations and IRB.
• Recruit qualified subjects for enrollment within sponsor timelines while adhering to ethics and ICH guidelines.
• Complete required training in a timely manner.
• Schedule and conduct patient visits per protocol requirements.
• Maintain accurate source documentation of visits and protocol-related activities.
• Complete CRFs/eCRFs and sponsor worksheets accurately.
• Maintain confidentiality and HIPAA compliance in duties.
• Report adverse events promptly to supervisor and PI/Sub-Investigator (within 24 hours for SAEs).
• Manage study materials and ensure availability for conduct of the study.
• Communicate with Team Lead, Team Manager, PI, and other team members.
• Attend trainings and investigator meetings as directed.
• Perform duties safely and as assigned.

Kenntnisse

Clinical research

Leadership

Communication

Multi-tasking

SOP writing

Ausbildung

Bachelor's degree

Tools

Office 365

Jobbeschreibung

About Us:

Flourish Research is where clinical trials thrive.Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WESEEYOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

About the Job:

We are actively hiring a Clinical Research Coordinator to supportour Detroit, IL site.

Shift: Monday-Friday day shift (40 hours per week)

Location: Onsite, Detroit., IL

FLSA Classification: Non-Exempt

Compensation: $30 to $35 per hour (depending on experience)

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 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.

ESSENTIAL JOB FUNCTIONS

• A. Read, understand, and can accomplish protocol specified patient visits and procedures.
• B. Clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs.
• C. Obtain patient informed consent according to federal regulations, GCPs and IRB requirements.
• D. 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.
• E. Complete all required training in a timely manner.
• F. Schedule and conduct patient visits according to protocol requirements and timelines.
• G. Maintain accurate and complete written source documentation of patient visits and protocol related
• activities.
• H. Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets generated by the
• sponsor.
• I. 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.
• J. Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed
• necessary.
• K. 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.
• L. 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.
• M. Maintain ongoing communication with Team Lead I; Team Manager; Principal Investigator; SubInvestigators and other people assisting with the trial and documenting these communications according to protocol requirements and Flourish policies.
• N. Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and Flourish policies.
• 11/05/2024
• O. Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
• P. Attend Investigator Meetings and/or other training as directed.
• Q. Perform all study-related duties in a time- and cost-effective manner in adherence with Flourish
• policies.
• R. Perform all duties in a safe and prudent manner.
• S. Perform other duties as assigned.
• T. 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.
• U. Additional duties as assigned by management.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS

• A. Work is normally performed in a typical interior/office work environment.
• B. Travel required.
• C. Exposure to human bodily fluids.
• D. Laboratory processing procedures.
• E. Subject/Patient care.
• F. Daily computer use.
• G. Occasional night and weekend work schedules.
• H. The ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
• I. 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 2 years’ experience as a CRC, plus 1-3+ years’ minimum experience within the field of clinical research or biological research.

Knowledge and Skills

• A. Exceptional knowledge of clinical research methods.
• B. Strong management and leadership skills.
• C. Demonstrated ability to collaborate and align with operations.
• D. Excellent oral and written communication skills.
• E. Excellent computer skills to include Office365 products.
• F. Experience in writing and reviewing Standard Operating Procedures.
• G. Strong problem solving, risk assessment and impact analysis abilities.
• H. Demonstrated experience in process improvement.
• I. Strong negotiation and conflict management skills.
• J. Flexible and able to multi-task and prioritize competing demands.
• K. Ability to think independently and influence when appropriate

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Researchcomplies withthe lawregardingreasonable accommodation for handicapped and disabled employees.