What are the responsibilities and job description for the Clinical Research Associate position at Actalent?
Immediate need for a Clinical Research Assistant to join a top pharmaceutical company based out of New Jersey! They are a specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias.
Description:
The candidate will be primarily responsible for assisting the Clinical Operations team in the execution of clinical trial deliverables in an effective and efficient manner. The candidate will be responsible oversight of investigational sites in the United States. This includes: overall site management, and monitoring (including start-up, initiation, routine monitoring, and close-out visits), monitoring inventory of ancillary supplies, file maintenance, and ensuring recruitment goals are met.
Requirements/Qualifications:
- At least 3 years as a full-time regional monitor working for a sponsor or Contract Research Organization (CRO)
- 5-7 years industry experience
- Experience with Phase 3
- Travel is required for the position, this may be extensive at times (up to 80%)
- Experience managing serious adverse events in collaboration with safety surveillance. Ensuring events are being properly followed to completion
- Extensive experience collaborating/interacting with counterparts at sponsor and other CROs/vendors (laboratories, drug depots, etc.)
- Experience managing clinical trial investigational sites
- Conducting site feasibility assessments, participating in or managing the site selection process, analyzing patient recruitment and retention rates
- Organize and perform site initiation visits and site training activities
- Perform periodic monitoring visits
- Verify biological sample collection, storage, and shipping procedures at the site
- Verify laboratory data is reviewed by the investigator, properly captured in the case report form, and if necessary, is being reconciled properly within the CRF
- Organizing and monitoring investigator study files
- Preparing and organizing local institutional review board(IRB)/ethics committee (EC) submissions in collaboration with the site(s) and Clinical Trials Associates
Additional Skills & Qualifications:
- Minimum of Bachelor’s Degree, preferably in life sciences
- The candidate must be able to perform the functions of the positions, which may include standing for long durations for filing purposes at the investigational sites, sitting for long durations during monitoring visits, and in some cases may require lifting of boxes and clinical trial materials not likely in excess of 30 lbs.
Pre-requisite Skills:
- Strong grasp of International Conference on Harmonisation Good Clinical Practice
- Experience collaborating and interacting with internal and external partners from a variety of cultural backgrounds and geographic locations
- Proficient in Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat
- Proficient in various electronic data capture and clinical trial management systems
- Must be well-organized and possess attention to detail
- Must have excellent verbal and written skills
Additional Benefits:
- Quick Access to Benefits: Medical, Vision, Dental, 401(k)
- Opportunity for growth and longevity
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
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $60 - $85
