Clinical Research Associate
Woodcliff Lake, NJ
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Research Associate in Woodcliff Lake, NJ. The Clinical Research Associate role will assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments, and participate in development of protocol, case report form, CRF guidelines and other study documents. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments
- Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.)
- Participate in development of protocol, case report form, CRF guidelines and other study documents
- Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal. Ensure the training of CROs/investigators on protocol, regulatory, Eisai SOPs and data issues
- Review and approve monitoring reports and ensures tracking of ongoing site issues
- Onsite monitoring may also be required
- 3-5 years in-house in large pharma
- Experience in Phase 3 global study trials in multi-functional areas
- Oncology experience highly preferred
- MUST have experience with data review and patient profile review
- Minimum of college degree in a relevant discipline
- Bachelor's degree in relevant scientific discipline 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.