Administrative Assistant (AA)

🗏Job Type

Full Time

The Administrative Assistant provides administrative and clinical management support to the Site Management & Monitoring Clinical Team and assists the study team in preparing, initiating and managing international clinical studies executed by the South African Affiliate. If applicable, assists with Investigator Site and Vendor Payments according to local Finance processes and Quantum.
The Administrative Assistant (AA) provides administrative and clinical management support to Site M&M personnel and assists them with the in-house organization, management and execution of projects and activities undertaken by Clinical Operations Site Management & Monitoring personnel assigned to clinical studies conducted within the country.
If applicable, creates a local trial file for the filing of Country specific information. Supports CRAs with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents. Supports CRAs with preparations for PSVs, SIVs, and COVs, as necessary
Supports local Clinical Team with the handling of Essential Documents, including Contracts and Archiving. Ensure the Investigator Site Files are created, contain the correct and complete documentation, and are shipped as appropriate to Investigator Sites. Internal / External Contacts and Interactions: Uses multiple technologies to maintain open and frequent communication with Site Management & Monitoring personnel. Maintains a positive working relationship with internal / external customers.
Acts as In-house support for CRAs during site visits (administrative tasks, point of contact etc.)
Acts as In-house support for CRAs with the handling and destruction arrangements of Investigational Product as, and if, required. This may include the entering of relevant information into Interactive Web-based Reporting Systems. Adheres to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs)
Participates in pre-audit activities to meet both PV and GCP Audit requirements. Supports CRAs to ensure audit and inspection readiness in clinical activities of responsibility. Ensures financial information for assigned studies / sites is entered in a timely manner and is managed in compliance with company policies (ex US). May participate in global Task Forces and Initiatives
Supports Clinical Team with the processing of Expense Reports and Travel arrangements. Supports with organizing Team Meetings (booking meeting rooms, taking minutes and organizing catering etc.) If appropriate, assists with the filing of training records and other relevant personnel documentation for staff
Actively participates in relevant Meetings, manages the collection and distribution of mail and courier requests and may act as a local liaison for CRO (Observational) Studies.
Assists with other general administrative and organizational matters related to the efficient operation of the SM & M Clinical Team, which may include (but not limited to):
Support with contract administrative tasks:
Uploads fully executed contracts to the local/global contract database and provides associated information for global database (OCTUS)
Proactively supports the clinical team to meet business needs.
Stationery and office supply order

Assisting with critical issue management
Documenting communication within affiliate staff including taking minutes as required
Support CRAs with the following items for all SM&M team assigned studies:
Implement and maintain TMF/eTMF
Act as a liaison for remote access issues
Maintains training files and tracks training records
Coordinates new employee set up and onboarding (training files)
May manage travel scheduling, domestic and international, with regards to flights, accommodation, car hire and visa requirements
Supports Managers with the following items:
May be requested to prepare expense reports
Requirements:

Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Ability to manage multiple priorities / projects, communication and interpersonal skills, including situations of conflict resolution, problem solving and crisis management. Proactive and positive team player.
Written and verbal fluency in English and local language (if not English). Familiarity with all standard IT office tools.
Proven ability to communicate effectively within a multi-cultural / global team environment.
Exhibits high level of flexibility when facing changes in the work environment
Ability to create a positive work environment by encouraging mutual respect, innovation, and accountability at all level

Candidates that meet the criteria may submit their CV to jobs@mnarecruitment com

Job id : , #76064, 131 views,

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