Client Trial Assistant
Woodcliff Lake, NJ
At Advanced Clinical, we’re excited to share with you a great opportunity at a growing organization committed to clinical excellence for the position of Client Trial Assistant. The Client Trial Assistant is located in Woodcliff Lake, New Jersey and will assist clinical staff with study management duties for assigned clinical programs to evaluate performance, safety, and efficacy of products and to satisfy applicable regulatory standards and internal requirements for worldwide clinical studies. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Assists with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies
- Evaluates clinical data and participates in clinical report generation
- Assists with resolution and follow-up of site issues
- Provides support and training for clinical study sites to ensure data integrity and protocol compliance
- Assists in preparation of study materials and/or training
- Tracks and maintains study documentation
- Performs data review, generating queries and reports
- Generates data discrepancies and reviews completed discrepancy documents
- Interfaces with representatives from key functional groups including Product Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs
- Assists with site and study start-up and closure activities
- Assists with publication of study data in medical literature and/or presentation at scientific meetings
- Prepares clinical case summaries
- Maintains accurate clinical study files
- Provides support for development of marketing materials to support product activities
- Contributes to ongoing SOP review and development
- Assists clinical staff with administrative support as requested
- Ability to travel 10-20% of the time
- 2 or more years of experience in clinical research required
- Proficient knowledge of medical terminology
- Knowledge of GCPs and other regulatory and compliance guidelines for clinical trials
- Ability to manage multiple clinical research sites with proven results in study execution
- Computer experience with knowledge of word processing and applications such as Word, Excel and PowerPoint
- Bachelor’s Degree required, preferably in engineering, life science, or related medical/scientific field
- Advanced Degree preferred in engineering, life sciences, or related medical/scientific field
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.