The Project Assistant works with Project Managers, Project Coordinators and Clinical Research Associates (CRA) at many stages during clinical studies. Works independently to coordinate and manage study deliverables and administrative tasks, as required by the project team.
More specifically, the Project Assistant must:
Participates and supports the project team for assigned studies with administrative tasks
Assists with maintenance of projects within the CTMS (i.e., trackers, contacts, etc.)
Verification and tracking of vendor and site invoices
Reconciles project team training against project specific training matrix
Follow-ups with team members for completion of the their project specific training
Assists with initiating and maintaining study files (eTMF)
Filing of email correspondences in eTMF
Supports with management of requests for system accesses
Supports the project coordinators with tracking, uploading and entering metadata for the site regulatory documents
May assist with tracking and review of the site close-out documents
May be assigned to the management of the study specific training in SOLABS
May update enrolment tracker (screened, randomized, screen failed) for assigned studies
May download site visit reports and site letters from CTMS and send for upload to eTMF
May assists with project tracking activities and status reports preparation
May support other groups within the Project Management department with various administrative tasks
Participates in various administrative tasks, as required, to accomplish the goals of the project and the needs of the project team
Requirements:
Experience in clinical research and in biotechnology, pharmaceutical, and/or CRO industry is an asset.
Proficient in English (oral and written)
Good knowledge and competency in Word, Excel, and PowerPoint.
Ability to prioritize multiple assignments to meet deadlines.
Attention to detail.
Quick learner, good adaptability and versatile.
Strong organizational, communication, problem-solving and multi-tasking skills
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