Clinical Research Associate
Woodcliff Lake, NJ
We are currently searching for a skilled professional to join a well-known client’s team as Clinical Research Associate in Woodcliff Lake, New Jersey. The Clinical Research Associate role will provide clinical study support for product development, and will also ensure successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures. As the Clinical Research Associate manages project timelines, contracts, internal/external communications, and more, their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Conducts standard pre-study, initiation, interim, and close-out monitoring visits
- Completes site visit reports
- Ensures site compliance with regulations and study protocol
- Identifies and qualifies clinical investigators and clinical sites
- Prepares clinical study documents
- Proposes and negotiates budgets for clinical studies
- Initiates payment to sites
- Obtains and reviews all required essential documents necessary for study initiation
- Reviews and monitors clinical data generated by Clinical Affairs
- Reviews data, then prepares and presents clinical data summaries
- Works with Data Management and Statistics on the design of documents and processes for the collection of study data from participating clinical sites
- Ensures accurate and complete study management/data collection and transfer into the data management system
- Responds to audits and data queries
- Maintains accurate and timely sponsor/site correspondence and communication
- Prepares and presents project progress reports to keep management and team informed
- Ensures compliance with Good Clinical Practices, regulations, SOPs, and protocols
- Acquires and maintains technical knowledge of product line
- Minimum of 3 years clinical related experience required
- Exceptional documentation skills, preferably in the FDA regulated industry
- Experience with clinical regulations and standards affecting IVDs
- Clinical Laboratory Certification (MT; ASCP or equivalent) or IVD experience preferred
- Up to 50% travel may be needed
- Bachelor’s Degree required, biological sciences or medical specialty preferred
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.