Project Assistant, Early phase (India)

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.

This role will be perfect for you if:

• You have experience working in clinical research and clinical monitoring in a Biotechnology, pharmaceutical and/or CRO industry
• You have strong Excel skills
• You have experience working with clinical systems including CTMS and eTMF

More specifically, the Project Assistant, Early Phase must:

• Participates and supports the project team for assigned studies with administrative tasks
• Assists with maintenance of projects within Smartsheet and CTMS if applicable (i.e., trackers, contacts, etc.)
• Verification and tracking of vendor and site invoices
• Reconciles project team training against project specific training matrix
• Monthly reconciliation of the project specific training matrix
• Export and send documents to the eTMF, according to the eTMF plan
• Follow-ups with team members for completion of their project specific training
• Assists with initiating and maintaining study files (eTMF)
• Filing of email correspondences in eTMF
• Support with system accesses: creating, management of requests and revoking
• Supports the project coordinators with tracking, uploading and entering metadata for the site regulatory documents
• Supports the project coordinator to resolve the eTMF queries
• Assist with tracking and review of the site close-out documents
• May be assigned to the management of the study specific training in SOLABS
• Update enrollment tracker (screened, randomized, screen failed) for assigned studies
• 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 with sending and/or collecting documents to sites
• Assist with the periodic review of study files, training documentation and CTMS for completeness (e.g. eTMF, project and systems training completion) and verify that actions items and protocol deviations have been pushed from the site visit reports to the CTMS library
• Prepare site information packages for CRA (e.g. required site follow-up from central monitoring activities, action items, protocol deviations, eTMF completeness, etc) in preparation for their upcoming monitoring visits
• Assist Clinical Research Associate (CRA), Site Visit Report Reviewer (SVRR), Central Monitors (CM) and other Clinical Operations team members with generating reports from clinical systems such as the EDC, CTMS, Smartsheet and TMF (e.g. reports on action items, protocol deviations, data entry and query status, source data verification status, etc…)
• Ensure CRA site assignments are up to date and accurate in CTMS
• Assist with the tracking of visits, site visit report compliance, and study documents
• May assist in the preparation, distribution, and filing of clinical documents and study supplies
• May support other groups within the Early Phase 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: **

Education:**

• Relevant education in science or clinical research

Experience:

• Experience in clinical research and in biotechnology, pharmaceutical, and/or CRO industry is an asset.

Skills and Knowledge:

• 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 and accuracy in work.
• Quick learner, good adaptability and versatile.
• Strong organizational, communication, problem-solving, time management and multi-tasking skills.
• Ability to work in a fast-paced evolving and global environment and establish good relationships with colleagues,
• Strong organizational, communication, problem-solving and multi-tasking skills.
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

Our company:

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule / work schedule :
• Home-based position
• Ongoing learning and development

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Innovaderm only accepts applicants who can legally work in India.