Clinical Research Coordinator I
Company: Fresenius Medical Care
Posted on: June 12, 2021
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
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
- 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
- Consults with PI regarding the appropriate administration of
- 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
- Informs/updates the subject about pertinent study details as
- 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
- 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
- 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
- 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
- Bachelor's Degree or an equivalent combination of education and
- Graduate of a technical program in healthcare (e.g. LVN/LPN,
Medical Assistant or Dialysis Technician) AA in Life Sciences or
other health related field. Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
- 2 to 5 years' healthcare experience with Dialysis experience
- Research experience preferred.
- Willing to pursue CCRC or SoCRA certification when
- 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
Fresenius Medical Care North America maintains a drug-free
workplace in accordance with applicable federal and state laws.
Keywords: Fresenius Medical Care, Houston , Clinical Research Coordinator I, Other , Houston, Texas
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