Clinical Research Nurse

HOURS ARE M-TH 8-5p NO WEEKENDS OR HOLIDAYS

Clinical Research Institute of Michigan, LLC is a medical research company with multiple locations. We are a primary Gastrointestinal research center with multiple active studies at this time. We are expanding and are looking for an experienced coordinator. We offer competitive pay and health insurance, and a substantial retirement package for full-time employees.

JOB DESCRIPTION:

The Clinical Research Nurse is responsible for the coordination and implementation of research protocols, including subject recruitment and enrollment. The Clinical Research Coordinator demonstrates working knowledge of federal regulations and protocols for the conduct of clinical trials and investigations and promotes good clinical practice and protection of human subjects.

DUTIES AND RESPONSIBILITIES

• Clinical Trial Subject Maintenance- Subject visits: scheduling visits, administering surveys in person or by telephone, obtaining of medical histories, collecting/processing biological specimens, entering data into electronic system, and responding to queries regarding study data. Subject records and documentation management. Monitoring subjects for safety and compliance with protocols. Analysis of patient data.
• Patient recruitment- Pre-screening patient medical records, calling or interviewing potential subjects face-to-face to confirm eligibility, and consenting for the above studies after exercising professional judgment on whether subjects meet inclusion and exclusion criteria.
• Regulatory Management- Effectively communicate with the Institutional Review Board (IRB) for clinical study approvals, amendments, and continuations. Organize and maintain clinical trial regulatory documentation, training, and delegation.
• Collect, process, and ship research specimens, including blood draws.
• Document and maintain all study related procedures and events. Prepare complex regulatory documents.
• Communicate effectively with subjects, research team, principal Investigators, ancillary staff, study sponsors and primary care providers.
• Consent and conduct study visits for device trials, data collection/no risk trials, and study article/some risk trials. Monitor for AEs, distribute device/study article and monitor device/study article's accountability as appropriate.
• Prepare for and participate in audits by sponsors and external regulators.
• Patient/family interaction – utilize effective communication skills; incorporate specific age, cultural or developmental needs.
• Assist in budget preparation; plan and implement study protocols with regulatory division.
• Protect subject confidentiality.
• REQUIREMENTS/QUALIFICATIONS
• Minimum 5 years of clinical research experience preferred.
• Ability to read and fully understand research protocols.
• Excellent interpersonal and professional skills to work effectively with others and provide superior customer service to patients/subjects and their families.
• Ability to handle confidential matters; adheres to all HIPAA guidelines/regulations.
• Understanding of medical terminology, procedure codes and diagnosis codes as it applies to recruiting subjects for research.
• Ability to communicate clearly and professionally, both orally and in writing with patients, team members, physicians, payers, and office coordinators. Knowledge of spelling, punctuation, grammar, sentence structure, and proper English usage.
• Ability to multi task duties, prioritize work load, organize files and work space and be self-directed in an open office setting.
• Strong proficiency in: MS Office Suite, including Word and Excel, Outlook or other email system, use of computerized medical tracking systems, use of insurance websites, internet search capabilities and other applications as appropriate.
• Strong analytical and problem solving skills.

Job Type: Full-time

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Physical Setting:

• Clinic
• Outpatient

Experience:

• Clinical research: 3 years (Required)
• Phlebotomy: 3 years (Required)

Work Location: In person