Clinical Research Associate
4 days ago
About the Role:
We are seeking a highly skilled Clinical Research Associate to join our team at Parexel International. As a Clinical Research Associate, you will be responsible for ensuring the overall integrity of study implementation and adherence to study protocol at clinical sites.
- You will act as Parexel's direct contact with assigned sites, building relationships with investigators and site staff.
- Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
- Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
Your Key Responsibilities:
Manage start-up activities, including feasibility and/or site pre-qualification and qualification visits.
- Conduct remote Qualification Visits (QVs) and generate visit/contact reports.
- Develop strategy to configure, distribute, collect, review and approve high quality country specific and/or site specific documents or essential regulatory documents (SRP).
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
Maintenance Activities:
Act as Parexel's direct contact with assigned sites during the maintenance phase, assessing and ensuring overall integrity of study implementation and adherence to study protocol.
- Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
- Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
- Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
Skills and Qualifications:
- Problem-solving skills and ability to work independently.
- Sound presentation skills and client-focused approach to work.
- Able to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Ability to manage multiple tasks and achieve project timelines.
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