CRA Job Description: Job Description

PURPOSE AND SCOPE:

Provides 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:

• Assists with obtaining and preparing 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.

• Under close supervision, ensures documents and forms are compiled and submitted in a timely manner to the 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.

• Under close supervision, interfaces with potential study subjects for the purpose of promoting participation in research studies.

• Assists with the screening of 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.

• Assists with 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.

• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and

• federal laws and regulations.

• Assists with various projects as assigned by direct supervisor.

• 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. 20% travel.

EDUCATION:

ï‚· High School Diploma required. Certified Medical Assistant preferred.

EXPERIENCE AND REQUIRED SKILLS:

• 0-1 year experience in a medical setting and/or clinical research preferred.

• Willingness to obtain research specific training as needed.

• Must be able to meet deadlines for multiple concurrent projects.

• Ability to understand and follow study specific protocol and direction.

• Ability to understand a dialysis medical record.

• Attention to detail a must.

• Proficient with PCs and Microsoft Office applications.

• Strong communication skills, verbal and written.

• Strong organizational skills.

• Ability to take direction.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Hourly Rate: $18.00 - $28.00

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.

Job Description

Market Summary

Under the direction of a Research Scientist, performs technical research tasks in support of quantitative and qualitative clinical research projects. Identifies data sources and collects, organizes and measures data in a manner that ensures quality control. Performs validation testing and interprets results for reporting.

Impact

• Obtains and provides information which requires little explanation or interpretation, typically within the department.

• Conveys information to parties within the department at an operational level requiring some explanation or interpretation in order to reach agreement.

Communication

• Interacts with internal stakeholders within own team and may also interact with external stakeholders including clients, customers, carriers or agents.

• Conveys information in accordance with standard guidelines and procedures primarily with internal parties who have shared interests.

Innovation

• Problems are typically of a routine nature, but may at times require interpretation or deviation from standard procedure.

• Tasks are straightforward, simple and typically impact own or one other department or specialty.

Knowledge

• Ability to identify problems and potentially update existing methods, techniques and/or processes in job area by following standard procedures and guidelines.

• Applies full knowledge of the job. Typically requires high school diploma and 2-4 years of experience, or an equivalent combination of training and experience.