Clinical Research Monitor Jobs

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Good problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Technical writing skills (protocols, CRF development, study tools)

Good computer skills in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery

Experience with electronic data capture preferred

3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required

Experience working in a medical device or regulated industry, preferred

Experience with electronic data capture, preferred

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Demonstrated problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs

Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Conducts site qualification, initiation, interim, and close-out visits

Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol

Travels to clinical study sites as required, including remote or onsite visits globally

Analytical problem-solving experience, trouble shooting and resourcefulness

3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required

Experience working in a medical device or regulated industry, preferred

Experience with electronic data capture, preferred

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Demonstrated problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required

Experience working in a medical device or regulated industry, preferred

Experience with electronic data capture, preferred

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Demonstrated problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Preferred Education, Experience and Skills:

SOCRA/ACRP (or equivalent) certification; Master’s Degree or other advanced degree in related field.

YCCI Clinical Research Associate (Monitor)

None - Not included in the union (Yale Union Group)

Click here to see our Wage Ranges

Total # of hours to be worked:

Perform remote and on-site monitoring & oversight activities in accordance with protocol, GCP/ICH Guidelines, and AFT SOPs.

Manage on-site medication accountability and inventory throughout clinical study.

In conjunction with the AFT IHCRA, manage and maintain information and documentation in CTMS and eTMF.

Minimum two years clinical monitoring experience required, with a strong preference for oncology monitoring experience

Deep knowledge of monitoring procedures and entire clinical trial process

Excellent organizational, leadership, and problem-solving skills