Phlebotomist/Lab Tech
On-siteSterling Heights, Michigan, United States
Job Summary
Participate in research participant screening, recruitment, and enrollment while conducting visits for data collection on no-risk or minimal risk trials. Collect, process, and ship research specimens as needed, then document study information in case report forms or electronic data capture systems. Handle data queries, maintain source documents, and organize all trial-related correspondence while implementing quality control and assurance methods. Assist with regulatory document preparation, adverse event reporting, and protocol deviation reporting under oversight. Maintain professional knowledge of clinical trials, protect patient confidentiality, and collaborate with physicians, nurses, and ancillary staff to ensure data integrity and meet deadlines.
Required Qualifications
- minimum of 1 year of clinical experience
- Phlebotomy skills
- Certification
- detail orientated
- ability to maintain organized records
- motivated to learn new things
- genuinely respectful of diverse points-of-view
- strive for an environment in which inclusiveness drives productivity and results
- Participates in research participant screening, recruitment and enrollment
- Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight
- Responsible for collecting, processing and shipping of research specimens, where applicable
- Documents study related information in case report forms or electronic data capture systems
- handles data queries and participates in monitoring visits
- Obtain, review and maintain source documents
- Maintains organization of all trial related documents and correspondence
- Implement quality control and assurance methods
- Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting
- Maintain professional and technical knowledge about Clinical trials
- Research participant/family communication
- protect patient confidentiality
Desired Qualifications
- strong interest in the Clinical Research field
- Expert database and computer skills: Microsoft Office (Word, Excel), Outlook
- excellent verbal and written communication skills
- ability to work independently and assume responsibility
- excellent organizational skills
- ability to meet data deadlines and maintain confidentiality
- Maintain data integrity within the department
- Maintain a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff
- Knowledge of FDA Regulations and Good Clinical Practices
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