Open to opportunities

Shilpa Venkat

@shilpavenkat

Message

Clinical Research Professional with 5+ years of experience.

India

Message

What I'm looking for

I seek a dynamic role in clinical research that fosters innovation and growth.

I am a dedicated Clinical Research Professional with over 5 years of experience in the Pharmaceutical CRO sector. My journey has equipped me with a robust understanding of clinical trials across diverse regions, including APAC, EMEA, and North America. I have honed my skills in site selection, project coordination, and quality management systems, ensuring that clinical studies are conducted efficiently and in compliance with regulatory standards.

At Innovaderm Research Inc., I excelled as a Site Selection Coordinator, where I developed and maintained productive relationships with key clinical research sites. My responsibilities included managing budgets, coordinating feasibility assessments, and ensuring the integrity of clinical trial documentation. My previous role at LabCorp Drug Development further solidified my expertise in project coordination and compliance, where I maintained project documentation and facilitated communication across global teams.

Experience

Work history, roles, and key accomplishments

Site Selection Coordinator

Innovaderm Research Inc.

Jun 2022 - Jan 2025 (2 years 7 months)

As a Site Selection Coordinator, I developed and maintained relationships with clinical research sites, managed the investigator database, and coordinated feasibility questionnaires. I also handled contract negotiations and ensured compliance with budget limits while updating necessary documentation in CTMS and eTMF.

Clinical Research Site Selection Management Budget Management Contract Negotiation CTMS ETMF Investigator Database Management Communication Project Coordination

Project Assistant and QMS SME

Innovaderm Research Inc.

Jun 2021 - Jan 2023 (1 year 7 months)

In my role as Project Assistant and QMS SME, I supported project teams by maintaining up-to-date documents in eTMF, verifying vendor invoices, and assisting with training reconciliations. I also facilitated the processing of document uploads in Solabs QMS and supported patient recruitment efforts.

Project Coordination ETMF Quality Management Systems Patient Recruitment Document Management Communication Team Collaboration Problem Solving

Clinical Project Coordinator

LabCorp Drug Development

Sep 2019 - Jun 2021 (1 year 9 months)

As a Clinical Project Coordinator, I maintained project documentation, updated internal systems, and coordinated with global study teams. I ensured compliance with SOPs and regulatory requirements while managing logistics for clinical trial sites.

Documentation Database Management Logistics Coordination Communication Quality Assurance Team Collaboration Time Management

Intern

Morningside Pharmaceuticals

Feb 2018 - Apr 2018 (2 months)

During my internship, I assisted in a bio-equivalence study, gaining practical exposure to the full life cycle of clinical studies, including site feasibility, initiation, monitoring, and close-out visits.