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 Clinical Research Associate. The Clinical Research Associate is located in Princeton, New Jersey and will be committed to providing centralized support to regional team members, and assisting with the preparation, organization and follow-up of investigator and study site selection. They will also lead site communications and clinical monitoring tracking, both at the local and international levels. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!
- Support site identification recruitment, and qualification, and selection
- Act as the primary contact for non-medical site questions
- Perform study tracking to ensure that all study files and documents are accurate, current, and complete
- Collect essential documents; then review, maintain, and close-out activities, ensuring that sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements, ICH/GCP guidelines, and SOPs
- Support the CRA and Lead CRA in order to manage the investigator sites and ensure compliance
- Develop and contribute to newsletters for assigned studies based on information provided by project teams
- Maintain FAQ list for assigned trials
- Confirm and track that all key site personnel have specific training
- Document site and sponsor contact and study interactions in a timely and professional manner
- Assist with resolution of investigational site/data queries
- Act as liaison with project team members regarding study site issues
- Provide quality review of the informed consent template
- Track submission to and approval from IRB, 1572 changes (including obtaining medical licenses and CVs related to these changes), correspondence, and site changes
- Experience in clinical trials at the CRO level required, in either healthcare or multiple therapeutic settings
- Experience required in maintaining clinical trial management systems (CTMS) and following applicable SOPs in clinical documentation
- Experience should include the provision of study-specific direction, training, and mentoring to CRAs and other team members
- Bachelor’s Degree or Associates Degree required, preferably in biology, healthcare, or pharmacy field of study
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.