Clinical Research Coordinator I

PURPOSE AND SCOPE:

This position supports Frenova Renal Research

Conceptually applies the research protocol to the clinical setting, seeing subjects in a clinical and dialysis setting. Maintains appropriate documentation associated with the assigned clinical study. Performs all duties as delegated and supervised by the PI and governed by Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines. Complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

General Administrative

• Continues to display a mastery of Senior Clinical Research Associate duties and responsibilities
• Adheres to Standard Operating Procedures (SOP), GCP, all regulatory practices as established by law, and company policies and procedures
• Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with Food and Drug Administration (FDA), GCP, and ICH Guidelines
• In collaboration with the PI, incorporates knowledge of protocol to identify potential study participants according to inclusion/exclusion criteria
• Develops processes for monitoring the status of study subjects as they progress through the study protocol assessment timeline
• Maintains up-to-date knowledge for operation and use of study specific equipment and technology
• Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of them during participation in a clinical trial
• Serves as an advocate for human subjects by establishing repour with participants through open, transparent communication
• Educates the subject on study protocol and procedures
• Maintains the study site files according to GCP
• Maintains subject participant records according to GCP
• Demonstrates initiative and actively seeks new opportunities for continuous learning by attendance at educational and professional development training opportunities

Conduct of Research

• Reviews source document templates for protocol accuracy identifying any errors or improvements needed to be made for data integrity prior to subject screening
• Performs tasks required by a protocol, which may include obtaining medical history, phlebotomy, Electrocardiogram (EKG), and other required tests, assessments, or procedures
• Develops in depth knowledge of study-specific requirements for reporting subject safety issues to the sponsor, institutional review board (IRB), FDA, and other regulatory agencies.
• Monitors, detects, and reports adverse events per the requirements of the sponsor, regulatory bodies, and site policies. Coordinates and gathers information from a variety of sources to ensure subject safety
• Prepares and submits regulatory documents in an accurate and timely manner under the supervision of the PI and appropriate management
• Utilizes or acquires knowledge of disease processes to recognize -subject’s change(s) in condition
• Regularly evaluates the study subjects’ condition and communicates concerns, with documented follow up to the PI, to ensure subject safety
• Accurately documents study subject activities as it pertains to the clinical study according to the principals of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)
• Maintains environmental integrity for investigational study product, administration, accountability, and storage according to study protocol and sponsor requirements
• Ensures appropriate storage, access, and maintenance of records pertaining to investigational product
• Conducts routine assessments to evaluate the subject’s response to and adherence to investigational product orders, and communicates observations/results to the PI, sponsor, and IRB as appropriate
• Consults with PI regarding the appropriate administration of investigational product
• Administers the investigational product according to the parameters of the study protocol, including local law, and under the direction of the physician
• Ensures safe handling of biological specimens
• Meets with the study monitor to review, verify, and correct all data entered onto the case report form and to ensure appropriate maintenance of study records
• Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed

Financial Management

• Tracks and coordinates potential site study subject stipend disbursement
• Ensures appropriate billing charge documents are submitted for reimbursement

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, facility staff and physicians. 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.

• The position requires 10 – 15% travel between assigned facilities and various locations within the community. Travel to regional, Business Unit and Corporate meetings may be required.

SUPERVISION:

• None

EDUCATION:

• Bachelor’s Degree or an equivalent combination of education and experience.

EXPERIENCE AND REQUIRED SKILLS:

• 2+ years’ healthcare experience with Renal experience preferred. Research experience preferred
• Willing to pursue CCRC or SoCRA certification when eligible.
• Current appropriate state licensure if applicable.
• Proficient with PCs and Microsoft Office applications.
• Good communication and organizational skills.
• Ability to work independently.

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.