Clinical Research Coordinator I - Jersey City, NJ
Company: Fresenius Medical Care
Location: Jersey City
Posted on: April 3, 2021
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Job Description:
We've updated our recruiting process and workplace settings to
help ensure the health and safety of our employees, candidates, and
communities during coronavirus. Learn more > Improve Healthcare
with Your career Clinical Research Coordinator I - Jersey City, NJ
We are leveraging virtual technology to engage with you and keep us
all safe while you explore a career with us. We will conduct all
interviews virtually, to allow us to still connect about this job
and proceed with our hiring process while practicing social
distancing. 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. 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
documents 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:
Bachelor's Degree or an equivalent combination of education and
experience 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 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. Benefits of working in the charming cities
or towns of OR and WA. Discovering the Dallas - Ft. Worth area.
Join Our Talent Network Let's stay connected! Joining our talent
network allows us to send you company news, career event
announcements and new job opportunities. As a company with over
64,000 dedicated employees, Fresenius Medical Care North America is
quite aware of the many scams that job seekers may face. If you
receive any type of communication on behalf of Fresenius Medical
Care North America that seems inappropriate or suspicious, we urge
you to report this activity to: Fresenius Medical Care North
America maintains a drug-free workplace in accordance with
applicable federal and state laws. If you are a recruitment agency
submitting a resume on behalf of a client: Fresenius Medical Care
North America (FMCNA) only accepts resumes from agencies on the
preferred supplier list and all third party searches require Human
Resources approval. Please do not forward resumes to our applicant
tracking system or to FMCNA employees and/or FMCNA Management.
FMCNA is not responsible for any fees or charges associated with
unsolicited resumes or third party searches conducted without Human
Resources approval. If you are interested in applying for
employment with Fresenius Medical Care, NA and require special
assistance or accommodation during any part of the pre-employment
process, please contact our dedicated Help Desk for assistance at
(855) FMCNAHR. All qualified applicants will receive consideration
for employment without regard to race, color, religion, sex, age,
pregnancy, marital status, national origin, citizenship status,
disability, military status, sexual orientation, gender identity,
genetic predisposition or carrier status or any other legally
protected characteristic.
Keywords: Fresenius Medical Care, Jersey City , Clinical Research Coordinator I - Jersey City, NJ, Healthcare , Jersey City, New Jersey
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