WE ARE INSIGHT: Envisioning and implementing a holistic approach to neurological treatment is our goal, and our unique research and powerful solutions illuminate the path toward greater innovations for the future of healthcare. Patients and families seeking effective surgical procedures, rehabilitation, and neurological treatment can trust in our highly skilled and renowned surgical team. As we provide comprehensive services at our state-of-the-art inpatient and outpatient facilities, we remain driven by our basic oath to help patients heal while providing a genuine, human touch.
The Clinical Research Coordinator (CRC) will work collaboratively with a multi-institutional team. The CRC will support principal investigators, work as a link between sponsor and institute, oversee details of clinical studies and ensure compliance with study review board and clinical research regulations. The CRC can be part of multiple research projects and should have the ability to multi-tasks.
Duties - 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 study-specific 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 study-specific source document binders for each study and subject.
- Maintain regulatory documents required for study site, sponsor, and IRB for initiation, interim reports, and close-out 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 close-out and ensure meeting sponsor deadlines.
Requirements
Education: - Bachelor's degree in health-related 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 detail-oriented 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, non-clinical, 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 fast-paced, 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.
Benefits:
- 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 long-term disability and basic life insurance - after 30 days of employment
Insight Employees are required to be vaccinated for COVID-19 as a condition of employment, subject to accommodation for medical or sincerely held religious beliefs.
Insight is an Equal Opportunity Employer & Values Workplace Diversity!
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