Description
We are seeking a Clinical Research Associate to perform monitoring and site management work to ensure that sites are conducting studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Responsibilities:
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits)
- Work with sites to adapt, drive and track subject recruitment plans in line with project needs
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Collaborate and liaise with study team members for project execution support as needed
- May be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirements
Requirements:
- Bachelor's degree in a scientific discipline or healthcare preferred
- 1+ years of CRA and on-site monitoring experience
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Written and verbal communication skills in English and Serbian language
- IT literate
- Active driver with a valid driver's license
- Located in Serbia