The Sr. Project Assistant is responsible for providing administrative and technical support to Project Team including planning, organizing and coordinating responsibilities of project administration. Maintains procedures, guidelines and documentation. Ensures appropriate maintenance of project records and that all regulatory documents are correct, processed and approved. Completes data entry and maintenance of data base repositories. Assists in preparation or creation of reports and completes data collection for analysis. Completes quality review and demonstrates audit readiness.
- Assists on project management ad-hoc activities, producing reports or on study plan edition.
- Serves as a resource to the project team.
- Maintains vendor trackers.
- Processes and tracks local regulatory, study specific or department documents.
- May assist with translation materials and translation QC upon request.
- Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance.
- Maintains a basic knowledge of project protocol and the ability to implement project plans with specific guidelines and accountable for meeting applicable project timelines in accordance with the contract.
- Provides clarification and resolution of findings related to documentation.
- Composes, copies and distributes communications, reports, documents and forms. Performs mass mailings and communications.
- Coordinates team conference calls and completes and distributes meeting minutes from internal/client/vendor meetings as applicable.
- Provides accesses to company, client and vendor systems.
- Completes review, coordination and compilation of files and other materials. Distributes project documents and supplies.
- Processes local payments (translations, EC/IEC, other local vendors, etc.)
- Performs file review. Organizes and maintains correspondence files and other departmental records. Analyzes and reconciles project documents, metrics and findings reports within specified timelines.
- Strong customer focus
- Good presentation skills
- Strong flexibility to reprioritize workload to meet changing project timelines
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Ability to work in a team or independently as required
- Firm computer skills, proficient in MS Office, ability to obtain knowledge and master all database systems and modern technology
- Demonstrated ability to attain and maintain a good working knowledge of applicable regulations and procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout
- Solid English language and grammar skills
- Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Skills to work under constant pressure to meet project/client deliverables and timelines
- Solid critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Qualification & Experience:
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- 3-4 years of administrative support experience with emphasis on word processing database entry, spreadsheet usage, and detailed filing (applicable clinical research experience can be substituted for part of administrative support experience)
- Or an equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities
Vacancy Type: Full Time
Job Location: Raleigh, NC, US
Application Deadline: N/A