Description: This CTE will follow the conduct of a clinical study from site selection and initiation through repetitive education and training of health care professionals solving complex research questions until the end of patient enrollment. You will have the chance to work on a study featuring complex or non-traditional patient pathways compressed timelines for diagnosis and enrollment and protocols requiring intense initial education and ongoing reinforcement. You will be able to accelerate patient enrollment improve site performance and help streamline study related processes. Clinical Trial Education analysis of data for optimal site selection Expedited contracts and documentation completion Responsible to facilitate trainings vendor readiness system access study supplies IP patient waitlist review and prescreen database Review patient scheduling and availability Manage and assist with Site Opening Acceleration Develop key relationships and begin pre-screening activity Continuously increase and sharpen therapy and technical knowledge as well as presentation skills. Responsible for being able to conduct scientific / technical presentations and discussions on renal therapy. Support study and therapy awareness at site and beyond Keep study Top of Mind on site interactions Weekly communication and study updates Chart Review/Pre-Screening Logs/EMR Alerts ICD-10 Identify patient pathways Track patient logs and outcome Proactively address barriers to recruitment Oversee and manage communication and reduce handoffs and redundancies Liaison between the site study team and the sponsor to prevent fall through Facilitate the sharing of best practice globally Assumes other duties as assigned by the Supervisor. Skills: Clinical Research, Clinical Trial Educator, Dialysis, Renal, FDA, ICH GCP, ICH GCP, Nurse, Site Selection, Study Enrollment Top Skills Details: Clinical Research,Clinical Trial Educator,Dialysis Additional Skills & Qualifications: FDA GCP regulations for medical communications. Excellent presentation and teaching skills. Solid knowledge of good clinical practice guidelines and ability to implement Must be able to provide guidance and training to the team supervising regarding applicable regulatory and legal requirements and guidelines Solid knowledge of FDA regulations for medical communications. Excellent medical writing and oral communication skills. Solid know ledge of Acute Therapies (Dialysis) and competitor products and therapies High flexibility and ability to travel Bachelors degree and a minimum of 5 years of clinical experience is required advanced degree in a scientific discipline is preferred. Clinically skilled licensed health care professional in Nursing Pharmacy or other allied health profession. Degree of ICU or Dialysis nurse is preferred Recent or ongoing work in a clinical position is desirable as is experience in teaching/in-servicing other health care professionals. Minimum of 5 years clinical experience. Experience as therapy specialist is desirable Experience Level: Intermediate Level About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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