Clinical Research Associate (CRA) with relocation to Tbilisi, Georgia. Be a part of Global Team Dr. Reddy's!

Mandatory: fluent English. Georgian - written and spoken, sufficient to read documentation and communicate with regulators.

Role Responsibilities:

• Act as DRL’s direct contact with assigned sites, assess and ensure overall integrity of study
• Implementation and adherence to study protocol at clinical investigational sites, and resolve site issues. Escalate issues that were unresolved to COL/PL.
• Build and maintain 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.
• Ensure adequate oversight to clinical trial by Investigator throughout.
• Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation and communication.
• Address/evaluate/resolve/escalate issues pending from the previous visit, if any.
• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
• Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents, IRB / IEC periodic updates as applicable.
• Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
• Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Conduct remote visits/contacts as requested/needed and generate visit reports, as applicable
• Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
• Review & follow-up site payment status.
• Follow-up on CRF data entry, query status, and SAEs.
• Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
• Review / QC of TMF (Site / country part) includes review of ISF (during on site MVs) and CIFs (in house)

Requirements:

• Good understanding on conduct of clinical trials, awareness about regulatory guidances for the conduct of clinical trials in India and other regularatory agencies'
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), electronic CRF (at least few platforms), RTSM or any other study related platforms / portals and MS-Office products such as Excel and Word.
• Minimum of 2 - 4 years of relevant experience; preferred with experience of handling of Global clinical trials;
• Knowledge of ICH GCP, applicable local regulations;
• Proficient computer skills (MS office, Sharepoint management);
• Language skills- Bi-lingual (English and local language proficiency)