POSITION FEATURES:This position supports the Frenova Renal Research division and is located in the Mishawaka, IN clinical site.PURPOSE AND SCOPE:Works under the supervision of the Principal Investigator (PI), Director and other site personnel as applicable. Conceptually applies the research protocol to the clinical setting to allow accurate and timely completion of all duties. Maintains appropriate documentation associated with the assigned clinical study. Ensures studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), ICH, and FDA guidelines.PRINCIPAL DUTIES AND RESPONSIBILITIES:
Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.
Under the supervision of the Principal Investigator (PI) and appropriate management prepares and submits regulatory documents in an accurate and timely manner.
In collaboration with the PI, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria.
Obtains informed consent according to GCP.
Schedules subject visits.
Prepares labs/tests per protocol.
Responsible for study drug storage and drug accountability according to the parameters of the study protocol and sponsor requirements.
Administers the investigational product according to the parameters of the study protocol and under the direction of the physician. LVNs/LPNs may administer medications under their state licensure and under the order of the PI. Non-LVNs may administer oral and subcutaneous drugs with appropriate training and under the license of the PI.
Monitors and evaluates patients’ condition with regard to the investigational product.
Consults with PI regarding the appropriate administration of investigational product.
Conducts routine assessments to evaluate the subject’s response to investigational product, and communicates observations to the PI, sponsor and IRB as appropriate.
Educates the subject about the applicable study particulars.
Informs/updates the subject about pertinent study details as needed.
Documents subject information as it pertains to the clinical study according to the principals of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate).
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.
Reviews all lab/tests with the physician in a timely manner.
Reports subject’s progress, complaints and issues to PI, study sponsor, or IRB as needed in a timely manner.
Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed.
Notifies appropriate management and external parties of serious adverse events according to protocol.
Collects pre-study essential documentsssential to protocolRB as neededccording tot he according to GCP and files appropriately in the study record.
Maintains the study file record according to GCP.
Maintains subject participant records according to GCP.
Provides a list of all study participants to facility/practice management to avoid improper billing of lab tests or services covered under the research budget.
Ensures appropriate storage, access, and maintenance of records pertaining to investigational product.
Documents investigational product received dispensed, and returned to study sponsor according to GCP.
Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
Attends Investigator Meetings as necessary.
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, 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:
Combination of education and health care experience, such as graduate of a technical program in healthcare (e.g. LVN/LPN, Medical Assistant or Dialysis Technician) or associate degree in life sciences
Bachelor’s Degree, preferred
EXPERIENCE AND REQUIRED SKILLS :
2 to 5 years healthcare experience
Clinical research experience preferred
Nephrology experience desirable
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 IdentityFresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.