Regional Clinical Research Associate
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 Regional Clinical Research Associate. The Clinical Research Associate is located in Princeton, New Jersey and will work in an interdisciplinary environment to assess patients, facilitate the plan of care, implement care progression, and evaluate options and services to meet an individual patient’s health needs. As they effectively communicate, collaborate, and coordinate to facilitate efficient clinical care progression, their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!
- Conduct monitoring activities at a clinical site for one or more clinical trials
- Responsible for multiple projects at one time
- Follow Standard Operating Procedures (SOPs)
- Attend project-specific training and client meetings as needed for the clinical trial
- Create materials as needed to successfully execute assigned responsibilities
- Perform source data verification
- Review regulatory documents and drug study
- Prepare trip reports as outlined in the Monitoring Plan
- Must travel nationally up to an average of 80%, depending on project needs
- Minimum 1-3 years of monitoring experience or a combination of on-site monitoring and clinical research experience/education required
- Experience in scientific discipline and multiple therapeutic areas preferred
- Industry certification preferred
- Must have experience/training in the following areas: Applicable Standard Operating Procedures, Good Clinical Practices (i.e. GxP Regulations; ICH Guidelines; Good Quality Practices), 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process, Data Management Overview, Sponsor/Study specific trainings, and other applicable system training
- Proficiency in MS Office including Word, Excel, and PowerPoint required
- Bachelor’s degree, RN, or Associate’s Degree required
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.