OverviewAbbVie Clinical Project Assistant Part Time in Mascot NSW
Branch Mascot NSW AU
Clinical Project Assistant
Join AbbVie – combining the focus and passion of a leading-edge biotech with the expertise and structure of a long-established pharmaceutical leader….
Awarded Great Place to Work Australia 2014
Top-30 Most Innovative Companies in Australia 2014
People. Passion. Possibilities.
Join AbbVie – combining the focus and passion of a leading-edge biotech with the expertise and structure of a long-established pharmaceutical leader.
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PURPOSE OF JOB
The Clinical Project Assistant (CPA) assists local Clinical Research personnel, 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.
The key impact of this role is to ensure, through their contribution to the local Clinical team, that Site Management & Monitoring fulfils its commitment to the global organization.
If applicable, creates a local trial file for the filing of Country specific original documentation.
Supports CRAs with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents.
If applicable, supports CRAs with translation of Clinical Study documents.
Supports local Clinical Team with preparations for PSVs, SIVs, and COVs, as necessary.
Supports local Clinical Team with the handling of Essential Documents, including Contracts and Archiving.
Ensures the Investigator Site files are created, contain the correct and complete documentation, and are shipped as appropriate to the Investigational Sites.
May be assigned as the local Updater of databases (such as IMPACT) with Country related data, if applicable.
If applicable, assists in forwarding safety information to the appropriate group.
Acts as in-house support for CRA’s 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, AbbVie 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.
Anticipates and identifies issues that could affect the quality of data, systems or processes and develops alternative solutions, or ensures corrective action is implemented as appropriate.
If applicable, assists with Investigator Site and Vendor Payments according to local Finance processes and Quantum.
Ensures financial information for assigned studies /sites is entered into company systems 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 filing of training records and other relevant personnel documentation for staff.
If applicable, supports relevant Line Managers with the onboarding process of new staff.
Supports Affiliate Clinical Team with updates to local SOP’s and Work Instructions, when applicable.
Manages general Office Tasks for Site Management & Monitoring team such as the ordering of supplies and printing requirements.
Actively participates in relevant Meetings.
Manages the collection and distribution of mail and courier requests.
May act as a local liaison for CRO (Observational) Studies.
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.
May interface with and build professional collaborative relationships with:
Local personnel including Medical Department personnel and other AbbVie personnel within Clinical Operations as well as Safety Representatives, Regulatory, Finance and Legal Functions, Human Resources, administrative staff and other relevant functional areas.
Site Management & Monitoring personnel in other Countries and Document Management.
External service providers:
study personnel (investigators, study coordinators, pharmacists, etc)
peers within the organization Vendors
To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.
Responsible for the health, safety and environmental performance of themselves and others through compliance within EHS programs, regulations and standards. Subject to the policy and procedures outlined in the EHS Handbook.
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent schedule and is not part of the contract of employment.
Preferred background in life-science or healthcare-related qualification or experience is desired.
Preferred is a proven track record of success in a Site Management & Monitoring Department.
Basic awareness of the conduct of clinical trials and its associated activities and responsibilities.
Preferred is a basic knowledge related to ICH/GCP Guidelines and applicable local regulations.
Previous Administrative experience is desired.
Proven negotiating skills, tact and diplomacy.
Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Proven ability to manage multiple priorities/projects.
Proven 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.
To apply for this role, please send your CV and covering letter.
Please visit our website
for more information about our Company or to explore other AbbVie opportunities.
AbbVie is an EEO Employer.
Australia-New South Wales-Mascot
Employment Type: Part Time
Location: Mascot, NSW, AU
Posted on: 2015-07-29