Clinical Research Coordinator

• Provide technical support and assist Principal Investigators in study design and operations.
• Direct and coordinate clinical trials projects.
• Solicits industry trials for potential participation.
• Act as a main point of contact for study protocols and coordinate between clinical study team and CRO/Sponsor.
• Evaluate protocols and assist in study selection.
• Implement and ensure clinical trials operations and regulatory compliance.
• Review GCP guidelines maintain GCP/CITI certification and obtain studyspecific required certification for participating study staff.
• Manage all clinical trial patients enrolled in studies discuss protocols and informed consents and ensure eligibility criteria and recruitment.
• Coordinate all study visits including site initiation study closeout external audits and monitoring visits.
• Create studyspecific source document binders for each study and subject.
• Maintain regulatory documents required for study site sponsor and IRB for initiation interim reports and closeout documentation.
• Assign tasks to other members of the research team ensure they comply with the protocols and ensure performing all protocol visits assessments and procedures.
• Maintain databases for all clinical trials.
• Report adverse events to the Data Safety and Monitoring Board sponsor IRB FDA and all governing bodies.
• Submit protocols and amendments to the IRB.
• Complete study source documentation complete study report forms via proposed procedure maintain proper study closeout and ensure meeting sponsor deadlines.

• Bachelors degree in healthrelated field with minimum one year experience as a CRC is required
• Two years healthcare related field experience or experience in human research.
• Clinical research certification
• GCP and IATA certification are required (or willing to obtain them within the first month of assignment).
• SOCRA or ACRP certification are preferred.
• Basic Skills:
• Medical terminology and knowledge of disease processes
• Working knowledge of clinical research design and regulatory requirements
• Analytical skills to gather and interpret research data.
• Excellent interpersonal verbal and written communication skills.
• Organized and detailoriented individual.
• Comfortable working in a team environment
• Capability to work under minimal supervision
• Proficient in spreadsheets and clinical research software.
• Understand clinical procedures regulations and be an excellent team player working with physicians nurses nonclinical laboratory and ancillary staff
• Capability to meet data deadlines and maintain confidentiality
• Ability to travel to INSIGHT local offices when needed
• Behavioral Competencies:
• Ability to relate and work effectively with others.
• Demonstrated skills in verbal and written English communications for safe and effective patient care and to meet documentation standards.
• Proven excellence in patient safety and care.
• Friendly empathetic & respectful.
• Reliable in work results timeliness & attendance.
• Ability to relate to and work effectively with a wonderfully diverse populace.
• Able to work in a fastpaced and stressful environment while maintaining positive energy.
• Able to work under pressure and in situations that benefit from patience tact stamina and endurance.
• Detailed oriented conscientious and committed to precision in work results.
• Committed to contributing to a positive environment even in rapidly changing circumstances.
• Is aware of standards and performs in accordance with them.
• Able to provide eligibility for employment for any U.S. employer.

• Paid Sick Time effective 90 days after employment
• Paid Vacation Time effective 90 days after employment
• Health vision & dental benefits eligible at 30 days following the 1st of the following month
• Short and longterm disability and basic life insurance after 30 days of employment

Required Experience:

IC