Clinical Research Specialist
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Research Specialist in Memphis, Tennessee. The Clinical Research Specialist will oversee, design, plan and develop clinical evaluation projects. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Performs some administrative or coordinator duties as required (including calendar management, meeting minutes, filing etc.)
- Assists in the development of safety related portions of Study Protocols, Case Report forms, consent forms and other study related documents, resolves issues, reports outcomes to management
- Performs follow-up (queries) activities for safety cases
- Independently performs review of safety related CRFs, process adverse events received including performing event assessments
- Applies clinical judgement to determine adverse event reportability
- Conduct study specific event trending according to SOPs, and report outcomes to management
- Case quality review
- Event reconciliation activities
- Support internal/external audits and regulatory inspections
- Assists in response to FDA questions related to clinical safety
- Assists in authoring Safety related sections of regulatory reports
- At least two years of related experience in Clinical Research
- Familiarity with global regulations concerning clinical research and safety reporting
- Proficiency in Microsoft Office applications
- Familiarity with Safety and Clinical trial related databases
- Orthopedic and or Neurology experience
- Argus Experience, MedDRA coding experience
- Bachelors degree a life science or scientific related field, or RN or BSN degree, or other healthcare degree
- SOCRA or ACRP certification
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.