Job Description

Insight Institute of Neuroscience & Neurosurgery (IINN) aims to advance, challenge, and revolutionize neurosciences and medicine through scientific research and advanced technology, driven by a passion to help others regardless of any obstacles and challenges that may lie ahead. Our integrated team of medical professionals does so through creative, innovative techniques and care principles developed because of our continuous pursuit to improve the field of medicine. Our integrated team works together to find solutions to both common and complex medical concerns to ensure more powerful, reliable results. Having multiple specialties "under one roof" Insight achieves its purpose in providing a comprehensive, collaborative approach to neuromusculoskeletal care and rehabilitation to ensure optimal results. Our singular focus is Patient Care Second to None!

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. The CRC will report to the senior CRC and clinical research manager

Benefits for our Full Time Team Members:

• Comprehensive health, dental, and vision insurance coverage
• Paid time off, including vacation, holidays, and sick leave
• 401K with Matching; offerings vested fully @ 3 months of employment paired with eligibility to contribute
• Short & Long Disability, and Life Term insurance, complementary of Full Time Employment
• Additional Supplementary coverages offered @ employee's elections: Accident, Critical Illness, Hospital Indemnity, AD&D, etc.

Job Duties:

• Provide technical support and assist Principal Investigators in study design and operations
• Manage, and coordinate clinical trials projects
• 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 qualifications and selection questionnaires and visits
• Implement and ensure clinical trials operations and regulatory compliance
• Review GCP guidelines, maintain GCP and IATA/CITI certification and obtain study-specific required certification for participating study staff
• Manage all clinical trial patients enrolled in assigned 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
• Work on requested processes for protocols and amendments submissions to the IRB
• Complete study source documentation, complete study report forms via proposed procedure, maintain proper study close-out and ensure meeting sponsor deadlines
• Performs all other duties as needed per assigned study protocols

Qualifications:

• Ability to demonstrate authorization to work in the U.S. for any employer
• 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
• 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

Insight is an equal opportunity employer and values workplace diversity!

Job Tags

Holiday work, Full time, Interim role, Local area,

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