Responsibilities:

Assumes responsibility of effective management of research protocols initiated including but not limited to:

• Patient recruitment and consent including scheduling and retention in addition to scheduled study visits
• Create protocol specific documentation, reference tools and source documents
• Manage patient visits, documentation and study binders
• Responsible for day-to-day regulatory management including DOA, SAE reporting, deviations and amendment review.
• Assures adherence to safety guidelines and protocol schedule for patient treatment with oversight by Principal and Sub-Investigators
• Organization and coordination of Monitor/audit visit as required
• Responsible for EDC date entry and addressing any queries generated
• Train and conduct protocol specific assessments
• Additional responsibilities as assigned

Minimum Qualifications:

• 2 years of relevant experience in clinical research
• Blood draw experience
• Experience with EDC and Source Data
• Basic understanding of regulatory guidelines
• MS Office

Skills:

• ECG experience
• Lung function testing experience
• Phlebotomy
• Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
• Excellent written and interpersonal skills to effectively deal with patients, clinicians, administrators, regulators, monitors and sponsors
• Confident self-starter

Job Type: Part-time
Pay: $30,000.00 - $35,000.00 per year

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Farmington Hills, MI 48336: Reliably commute or planning to relocate before starting work (Required)

Work Location: In perso

Please refer the Job description for details