Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Kalamazoo, MI
View more jobs in Michigan

Job Details

Clinical Research Coordinator

Company name
Renal Advantage Inc.

Location
Kalamazoo, MI, United States

Employment Type
Full-Time

Industry
Clinical Research, Pharmaceutical, Research, Healthcare, Bluecollar

Posted on
May 24,2019

Apply for this job






Profile

Job ID 19000BICAvailable Openings 1PURPOSE 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 mannerAttends 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. EDUCATION: Bachelor’s Degree required. 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  ,identifier:19000BIC,qualifications: 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. EDUCATION: Bachelor’s Degree required. 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  ,title:Clinical Research Coordinator,url:https://jobs.fmcna.com/job/kalamazoo/clinical-research-coordinator/488/12004326,hiringOrganization:{@type:Organization,name:Fresenius Medical Care},jobLocation:{@type:Place,address:{@type:PostalAddress,addressLocality:Kalamazoo,addressRegion:MI,addressCountry:United States,streetAddress:,postalCode:49007}}}

Company info

Renal Advantage Inc.
Website : http://www.renaladvantage.com

Similar Jobs:
Drug Product Investigator
Location : Kalamazoo, MI
Drug Product Investigator Pfizer • Kalamazoo MI 49048 Job #1018778734 ROLE SUMMARY The Drug Product Investigator role will have site-wide responsibility for providing real time Method 1/Pfizer Human Performance (PHP) coaching, exe...
Patent Searcher
Location : Kalamazoo, MI
Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic product...
Pharmacy Manager
Location : Plainwell, MI
Apply Now Pharmacy Manager St Vincent's Health System Plainwell MI Apply Now Email this job Save NEW Full Time Mgr-Pharmacy - Pharmacy Services IP 003 - Full-Time,Day - Ascension Borgess Pipp Hospital - Plainwell,MI Why Join Ascen...