Clinical Research Specialist
Lake Zurich, IL
We are currently searching for a skilled professional to join a well-known client’s team as Clinical Research Specialist in Lake Zurich, Illinois. The Clinical Research Specialist role is responsible for project management, implementation and completion of in-house Donor Room and external activities related to all aspects of the sponsors medical device trials. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Site initiation including review of trial requirements, GCP, GDP, AE/SAE with site staff and investigator Assists in identifying and performing initial qualification visits of potential sites
- Manage start-up activities, perform continual monitoring of sites, track subject recruitment, enrollment, site issues and reporting of specific trial issues
- Support research with both in-house R&D and external clinical studies
- Conducts laboratory assessments as required
- Serve as the primary contact with investigators and staff for assigned studies
- Develop clinical study protocols, informed consents and training materials for assigned studies
- Prepare Excel spreadsheets as database for collection and storage of trial data
- Develop clinical protocols, investigator brochures as applicable, training materials, informed consents and assist with data collection tools
- Obtain required clinical inventory approvals per SOP
- Ensure all investigational materials (drug and device) are available, distributed, documented and reconciled accurately
- Assist with the negotiation of budgets and contracts related to each project including clinical sites and contract laboratories
- Prefer 3-4 years of clinical monitoring experience in pharmaceutical, biotech or medical device industry
- Familiar with FDA 21CFR, ICH Guidelines, HIPPA, other applicable local regulations
- Good Documentation Practices, Good Clinical Practice
- Minimum of Bachelor’s Degree required
- Advanced degree in 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.