Human Factors/Clinical Trials Project Managers

Working within a fast paced, busy environment for leading global pharmaceutical, biotechnology and medical device industries, our Project Managers act as the functional Lead with responsibility for delivery of all aspects of Human Factors testing/market research/clinical trials ensuring consistency with sponsor SOPs, study contracts and budgets. 

Our Leads take on the responsibility for planning, scheduling and implementing primary operational functions of your projects.

  • Manage cross functional teams

  • Responsible for risk mitigation strategies, action plans and issue resolution

  • ‚ÄčCollaborate with Business Development (BD) to ensure timely completion of change orders

  • Responsible for project deliverables, timelines, and budgets

We Provide In-House and Outsourced Professionals With Extensive

Therapeutic Experience in Human Factors Testing and 

Phase I-III and Post-Marketing Studies

Clinical Research Associates (CRAs)

Our contract CRAs are responsible for Clinical Monitoring of assigned projects and sites in accordance with Sponsor SOPs, Good Clinical Practice, ICH Guidelines, local regulations and additional sponsor requirements. CRA activities are performed in the interest of subject safety and vigilance against fraud. 

Our contract CRAs have excellent written and verbal communication skills along to carry out their duties:

  • Demonstrate management of all clinical investigative sites according to the Federal Code of Regulations, Good Clinical Practices, ICH Guidelines, local regulations, and Sponsor SOPs

  • Conduct monitor assessments, documents and communicates the growth and development needs to the Lead Clinical Research Associate (LCRA)/ Clinical Trial Manager (CTM) and Monitor Manager.

  • Maintain accurate and timely Sponsor/site communication and correspondence.

  • Manage time in accordance with allotted hours for task.

Therapeutic Experience

Our team has broad clinical experience and professional credentials in Health Science, Nursing, Psychology, and Clinical Trials Administration, Regulatory, and Biological Sciences.

Combining healthcare expertise with research and development to ensure safe and effective medicines, devices, healthcare products, and healthcare processes 

Call us at 512 663 5681

Regulatory Staff

Our team of regulatory professionals have greater than 15 years experience in medical device regulatory strategy for US and other regions.Regulatory Professionals