PURPOSE AND SCOPE:
Supports Frenova Renal Research by providing administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the Principal Investigator (PI), Director, and other site personnel as applicable. Responsible for the collection and submission of regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the PI and governed by Good Clinical Practice (GCP) and ICH guidelines, and assisting with ongoing study activity.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Utilizes experience and knowledge to act as a resource and provide on-going leadership and support to Clinical Research Assistant I, answering questions and providing assistance as needed
- Conducts on the job training for Clinical Research Assistant I as requested
- Researches and identifies research related issues and discrepancies when evident and appropriately escalates to site manager, Director, and/or principal investigator for resolution as needed
- Obtains and prepares regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms
- Ensures documents and forms are compiled and submitted in a timely manner to Frenova Renal Research, CRO, study sponsor or IRB as applicable
- Assists with maintaining constant communication with Institutional Review Boards, study sponsors, dialysis facility, practice and field staff as necessary to ensure timely study start-up or the effective and efficient progression of the study
- Assists with the contracting process, document preparation and execution as required during study start-up activities and throughout the duration of a study
- Interfaces with potential study subjects for the purpose of promoting participation in research studies
- Assists with screening subjects for participation eligibility using inclusion/exclusion criteria as outlined in the study protocol and under the direction of the PI
- Assists with and documents the obtaining of informed consent according to GCP
- Responsible for the timely and accurate data entry of study specific data into case report forms.
- Assists with addressing and resolving study sponsor questions, concerns, and queries in accordance with timelines established by the study sponsor
- Processes and ships study specific lab specimens as directed by the PI
- Performs study specific procedures at protocol directed intervals under the supervision of the PI
- Provides general support for research projects as directed by the PI, Director, or other site personnel
- Obtains and updates essential documents for specific studies, as necessary
- Attends clinical research-related training as required
- Assists with study close-out activities as directed by PI
- Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
- Escalates issues to supervisor for resolution, as deemed necessary.
- Assist with various projects as assigned by direct supervisor.
- Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
- Other duties as assigned
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Day to day work includes desk and personal computer work and interaction with patients, field staff, physicians and study sponsors.
- The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials.
- Must be willing to travel to other research dialysis facilities as needed. Travel to Regional, Divisional and Corporate meetings may be required. 10% travel is required.
High School Diploma required; Associate’s Degree or Certified Medical Assistant preferred.
EXPERIENCE AND REQUIRED SKILLS:
- 2-4 years of experience of related experience preferred.
- Minimum 18 months experience in a medical setting and/or clinical research setting required
- Willingness to obtain research specific training as needed.
- Ability to meet deadlines for multiple concurrent projects.
- Ability to understand and follow study specific protocol and direction.
- Ability to understand a patient medical record.
- Attention to detail required
- Good computer skills including MS Excel.
- Strong communication skills, verbal and written.
- Strong organizational skills.
- Ability to take direction.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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