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:
Ability to commute/relocate:
- Farmington Hills, MI 48336: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person