Project Coordinator , Early Clinical Development
Provide support and assistance to project managers and project teams related to the assigned project(s). Support all project-related activities for assigned projects in accordance with SOPs, policies and practices.
- Manage the set up and maintenance of all project documentation files, records and application files.
- Assist in the creation and/or review of study specific source documentation
- Coordinate all information and communications for assigned projects.
- Update and maintain internal databases including clinical capacity planner, tracking systems and project plans with project specific information.
- Maintain a safety lab result tracking system and work closely with the physicians to ensure subject safety, as is applicable to the clinical pharmacology unit.
- Assist Project Manager with Investigator Site File responsibilities.
- Determine and plan all meeting requirements in advance. Prepare presentation materials for meetings, as is applicable) (internal/external) and project summary data.
- Coordinate project team and customer meetings, as is applicable, identifying and planning appropriate medium (Web, teleconference, face to face) and ensuring arrangements are handled appropriately.
- Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly.
- Create and track project timelines as delegated by the Project Manager
- Manage complex study recruitment details as per protocol. Including completion of study preparation materials for the recruiting department, communication of recruitment timelines, and expectations, tracking study group membership in the recruiting database, and updating clients on study recruitment efforts, as is applicable to the clinical pharmacology unit.
- Reviewing volunteer charts as applicable and notifying volunteers of their study eligibility as is applicable to the clinical pharmacology unit.
- Coordinate with other project support staff within and across the Global Project Management Unit to identify and consolidate support processes.
- Ensure that work is conducted in compliance with standard processes, policies and procedures and meets quality and timeline metrics.
- Serve as primary backup contact for internal project team and for external stakeholders/customers. May also serve as primary project contact with sponsor under supervision.
- May assist the project manager(s) with budget allocation and approval of invoices as is applicable to the clinical pharmacology unit. Will undertake project management activities as directed by project manager
- Train and mentor more junior project support staff. Assist with guidance and supervision of lower level staff to ensure processes are carried out in line with protocols and local SOP’s.
- Develop, author, and review Quintiles Operating Procedures and Work Instructions
- Participate in quality and process improvement efforts to support a culture towards a high performing and efficient project coordination team.
- Act as a mentor/trainer to junior staff as directed by supervisor.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good communication and interpersonal skills
- Good problem solving skills
- Results and detail-oriented approach to work delivery and output
- Ability to work under limited direction
- Strong software and computer skills, including MS Office applications
- Ability to establish and maintain effective working relationships with colleagues and team members
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelors degree in life sciences or related field with 1 year of clinical research experience; or equivalent combination of education, training and experience
EEO Minorities/Females/Protected Veterans/Disabled
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