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Position Details: V02004-0201: Clinical Research Associate - Lead
| Location: | Multiple Cities, Multiple States |
| Openings: | 20 |
| Salary Range: |
Description:
Introduction:Imagine a career that touches the lives of
people everywhere. Imagine an opportunity to reach beyond your area of
expertise to make an impact on something greater than the bottom line.
Imagine playing a key role in some of the most critical issues facing
healthcare today. This is your career at a leader in the pharmaceutical/life sciences space - a career unlike any
other.
Position Details:
As a Lead CRA Site Manager (LCRSM), you will be responsible for facilitating communication and information flow between an assigned project team and the CRSMs within the PCO monitoring that project. The LCRSM's main interface is between the Study Manager and the assigned CRSMs as a primary point of contact. The Lead CRSM promotes professional respect and maintains communication between the project team and CRSMs to ensure that all CRSMs are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables. This individual will follow up with the project team as necessary to ensure satisfaction and resolution of issues, provide clarifications as needed, or obtain additional information as requested. The Lead CRSM is capable of performing duties associated with Study Start-Up, Study Maintenance, and Study Closeout as listed below..
Position Details:
As a Lead CRA Site Manager (LCRSM), you will be responsible for facilitating communication and information flow between an assigned project team and the CRSMs within the PCO monitoring that project. The LCRSM's main interface is between the Study Manager and the assigned CRSMs as a primary point of contact. The Lead CRSM promotes professional respect and maintains communication between the project team and CRSMs to ensure that all CRSMs are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables. This individual will follow up with the project team as necessary to ensure satisfaction and resolution of issues, provide clarifications as needed, or obtain additional information as requested. The Lead CRSM is capable of performing duties associated with Study Start-Up, Study Maintenance, and Study Closeout as listed below..
Key Capabilities:
- Communicate monitoring interval requirements to assigned CRSMs as determined by the Study Monitoring Plan
- Assist with Investigator Meeting and agenda contents
- Prepare CRSMs for Investigator Meetings
- Provide training
- In collaboration with Clinical, provide therapeutic and protocol training to the assigned CRSMs and maintain training documentation
- Maintain communication and information flow between the project team and assigned CRSMs during the course of the study as the primary point of contact, serving as primary point of contact for site study staff as well
- Provide additional training for newly assigned CRSMs or for those who could not attend the investigator meeting
- Serve as a point person and resource for the CRSMs.
- Focus heavily on recruitment strategy with on site visits as needed and sharing of best recruitment practices
- Lead/Facilitate teleconferences with CRSMs when appropriate.
- Provide back up coverage for site staff questions when assigned CRSM is unavailable
- Work throughout Company's matrix.
Qualifications (ideal candidate will possess most if not all of the following):
- B.S. degree in Life Sciences or equivalent
- 4-5 years of experience in the pharmaceutical industry, preferably in clinical research
- Excellent written and verbal communication skills
- Excellent organization skills
- Knowledge of the therapeutic area pertaining to the assigned project
- Strong leadership and diplomacy skills in a team environment
- Performance that exceeds the expectations of the CRSM position
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