Clinical research assistant
Location
Pennsylvania | United States
Job description
This job opportunity is with a clinical stage bio-pharmaceutical company that is focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. They are looking to add a Clinical Operations Manager to their team! The team is actively interviewing candidates and the organization has great culture!
Description: - Lead and manage the clinical monitoring network in the United States.
- Lead clinical operations in the United States in support of the clinical research trials.
- Train and develop clinical research associates (CRAs).
- Coordinate with the Clinical Project Managers in execution of monitoring and site management
deliverables.
- Ensure overall clinical operations study timelines are maintained.
- Line management of CRAs.
- Assess CRA performs and address issues promptly.
- Assess and review investigational site metrics in collaboration with Clinical Project Manager(s) and
Head of Clinical Operations, USA.
- Serve as primary reviewer of monitoring visit trip reports.
- Maintain and track investigational site monitoring metrics.
- Function as a primary contact and partner for the Clinical Operations team.
- Ensure all clinical trial activities are carried out in compliance with Good Clinical Practices and
applicable FDA regulations.
- Establish and oversee day-to-day clinical monitoring performance, ensuring compliance with policies,
procedures, and standard.
- Provide input and feedback on the clinical strategic approach and the impact on the overall clinical
development plan.
- Collaborate with the Clinical Project team in review of clinical trial protocols.
- Develop clinical monitoring plans and review additional study plans for the clinical trial, including but not
limited to: Monitoring Plan, Safety Reporting Plan, Communication Plan, Risk Management Plan.
- Learn medical and scientific details of the study indications.
- Collaborate with internal partners and vendors for the management of clinical supply (investigational
product) logistics, accountability, and destruction, drawing support from the monitoring team.
- Perform additional duties assigned by line manager
Additional Skills & Qualifications: - 5 years’ experience- CRA Management and Oversight
- SOP development
- Review trip reports
- Coordinate with Project Manager
- Will be managing upwards of 8-10 CRAs
- Systems experience- IRT systems, EDC systems
- Strong understanding and training of Good Documentation Practice
- Strong knowledge of applicable FDA regulations and guidelines
- Must be well-organized.
- Must have excellent verbal and written skills.
- Some measure of flexibility will be necessary. Due to the international framework of the organization, there will be instances when meetings are scheduled during non-traditional hours.
- The ideal candidate must be able to work independently but consistently.
- Productive personal interactions are critical to this role. Must have good inter-relationship skills.
Education & Experience: - Bachelor's Degree required
- 6+ years of previous experience in the Pharmaceutical Industry/Contract Research Organization.
- Minimum of 5+ years of CRA Management and Oversight experience
- Experience with protocol management
WHY ACTALENT - Work with a dedicated career partner specialized in your scientific skill set
- We advocate on your behalf so you get what you want and need out of your job
- Get performance feedback, career advice, and access to ongoing professional development tools
- Build your career and learn new skills through projects as diverse as your curiosity
- You are eligible for benefits, sick-time, and competitive wages that are paid weekly
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email
[email protected] for other accommodation options.
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