Clinical Research Coordinator - Northville, MI

Job Title: Clinical Research Coordinator
 

Work Set-Up: Working On-site
Schedule: 24 hours per week.

Responsibilities:

• Phlebotomy is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role.
• Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including spirometry, and vital signs.
• Coordinate clinical research studies conducted by a supervising principal investigator.
• Update and maintain skills, training, and knowledge of current best nursing practices and topics related to clinical research.
• Safeguard the well-being of the subjects and ensure and maintain high standards:
  • Maintain a safe environment in accordance with Health and Safety policies.
  • Act as a volunteer advocate.
  • Address volunteer and visitor concerns proactively and take remedial action as required.
  • Assist staff, both registered and unregistered, in clinical coordinator practices and the delivery of care to the volunteer.
  • Report any deviation from normal practice to senior staff.

Support Study Conduct By:

• Reviewing the study protocol, case report form (CRF), other study documents, and electronic data capture systems.
• Participating in project meetings with the project team as needed.
• Performing clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents.
• Planning logistical activity for procedures as per protocol.
• Generating volunteer instructions.
• Identifying and obtaining required supplies and equipment.
• Preparing and delivering study-specific training materials, documents, and records.
• Troubleshooting study issues.
• Participating in huddles to ensure daily tasks assigned to team members are executed to the expected standards.
• Assisting with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness.
• Recruiting and screening volunteers for inclusion in the study based on pre-determined criteria.
• Orienting volunteers to the study and the site including the purpose of the study, procedures, and practical issues such as timelines for visits.
• Responsible for the correct administration and custody of study drug according to site standard operating procedures.
• Collecting, recording, and reporting clinical data and findings appropriately in case report forms (CRFs). Collaborating closely with the study investigator, informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
• Cooperating with the study monitor and reserving sufficient time for questions during monitoring.
• Following ICH GCP guidelines with regards to all study and patient activities.

Qualifications:

• Equivalent education and experience - High School Diploma and 1 years’ relevant work experience in clinical research
• At least 1 year experience working in a clinical research setting preferred.
• Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies.
• Working knowledge of clinical trials.
• Working knowledge of the principles of Good Clinical Practices (GCP).
• In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules.
• Skill in carrying out required clinical procedures.
• Working knowledge of medical terminology.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients.

Please note, this position is not eligible for sponsorship.

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