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İlan Tanımı
Supports AbbVie’s Medical Operations Manager (“MOM”), Clinical Research Associates (“CRA”), Assistant Clinical Research Associates (“Assist. CRA”) and any other clinical research personnel involved, in AbbVie’s organization, management and execution of projects to ensure the clinical studies are conducted, recorded and reported in accordance with the protocol, AbbVie’s standard operating procedures and applicable global, local and regulatory requirements and AbbVie’s objectives.
Sorumluluklar
KEY RESPONSIBILITIES
• Proactively supports AbbVie’s clinical team to meet business needs.
• Preparing and maintaining department study files.
• Assisting with critical issue management.
• Organizing, preparing and participating in internal and external meetings including – seminars, training meetings and workshops and setting up video- and teleconferences
• Documenting communication within AbbVie’s staff including taking minutes as required
• Support AbbVie’s CRAs with the following items for all team assigned studies:
- Implement and maintain TMF/eTMF
- Prepare Investigator Site files and essential documents to be sent to sites
- Prepare submission files to Regulatory Authorities and Ethics Committees and following up / collection of the approval letters
- Prepare submission files to all financial institutions
- Translate essential documents (e.g. Hospital EC submissions and approvals, cover letters and approval from Regulatory Authority and National Ethics Committee) for assigned studies, timely.
• Assists with other general administrative and organizational matters related to the efficient operation of AbbVie’s clinical team.
• Updates the related systems (TESLA, COSMOS etc.) for assigned studies as required by Abbvie SOPs.
• Assists AbbVie’s staff in ensuring adherence with the study specific plans (Monitoring Plan, data management plan etc), ICH GCP Guidelines, AbbVie SOPs and procedures and other study related activities and procedures.
• Assists AbbVie’s staff in preperation of contracts with vendors, sites etc, and following up the finalization of contract procedures (collection of signatures, stamp duties etc)
• Per local requirements, executes and tracks external payments (e.g. investigator, ethics committee) and assists in collection of the invoices for assigned studies.
• Supports creating a positive work environment by encouraging mutual respect, innovation and accountability at all levels.
• Interact and build professional and collaborative relationships with CROs and other service providers, Regulatory authority and/or Ethics Committees, peers and office-based personnel. Use multiple technologies to maintain open and frequent communication with AbbVie personnel.
Aranan Nitelikler
KNOWLEDGE
• University degree in medical sciences (Medicine, Pharmacy, Chemical Engineering, Biology)
• Fluency in English
• Proficient Keyboard Skills
• PC Skills (Word, Excel, Powerpoint)
EXPERIENCE
• Preferably minimum 6 months of industry internship experience in clinical research department or work experience as a study coordinator.
