Clinical Research Associate

Location: New York City
Job Type: Blijvend
Specialisation: Life Sciences
Salary: US$90000 - US$135000 per annum
Reference: BBBH10864_1658321031
Contact: Berry Moor
Email: email Berry
Primary Responsibilities:

* Prepare/review SIV slides and perform Site Initiation Visits to train and instruct site staff on the study requirements
* Assist in site activation
* Perform Monitoring visits to:
1.verify that source data and study database are accurate, complete and maintained properly
2.verify subject eligibility
3.verify protocol compliance, including safety reporting and drug handling
4.verify all study files are maintained and up to date
5. support site staff in preparation for study specific site audits and inspections
* Perform Close-out visits
* Perform Pre-study visits, if delegated by SSU
* Perform centralized and risk based monitoring activities
* Act as the main line of communication between the study PM/LCRA and the site staff
* Maintain study related trackers
* Prepare site visit reports
* Liaise with site staff to achieve patient recruitment targets
* Contribute to the development of study specific documents
* Support the study start-up team in preparation of submission packages and collection of site documents, if delegated by SSU
* Review of site visit reports
* Assist the study PM/LCRA in coordinating and supporting CRA activities


Requirements

Qualifications:
* Life science, healthcare, medicine and/or related degree
* Minimum 1 year of CRA experience
* Thorough knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements
* Good understanding of site management and monitoring
* The ability to perform site visits in an effective way and having performed all different types of site visits (Initiation visit, Monitoring visit and Close-out visits)

Skills:
* Strong written and verbal communication skills including good command of English language
* Representative, outgoing and client focused
* Ability to work in a fast-paced challenging environment of a growing company
* Administrative excellence with attention to detail and accuracy
* Proficiency with various computer applications such as Word, Excel, and PowerPoint required
* Strong organizational skills
* Needs to be willing to travel regionally
* Solid IT skills and clinical research Software Systems: MS office, eTMF, CTMS, eCRFs, eCOA
* Flexible, multitasking, can do mentality, strong communication skills