Fresenius Medical Care
Healthcare
ClinicalResearchCoordinatorII
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Research Coordinator II at Fresenius Medical Care. Skills: Clinical research, Data management, Regulatory compliance, Patient safety. Collect clinical research data. Ensure data accuracy”
What You'll Achieve.
Assure quality study outcomes; Ensure study enrollment goals are met; Ensure study resources are used efficiently; Ensure study budget is adhered to
Industry & Context.
Problem solving; Troubleshoot protocol; Strategize with participants
50% travel, Live in the Northeast, Travel to Michigan, Travel to Mississippi, Travel to Louisiana, Travel to Indiana, Travel to New Jersey, Desk and personal computer work, Interaction with patients, Interaction with facility staff, Interaction with physicians, Exposure to infectious diseases, Travel to regional meetings, Travel to Business Unit meetings, Travel to Corporate meetings
What They're Looking For.
Must Have
2 to 4 years of clinical research experience, Current state licensure, if applicable, Good computer skills: Microsoft Office minimally, Excellent communication and organizational skills, Ability to work independently, Exhibit diplomacy and problem solving skills
Nice to Have
Graduate of a technical program in healthcare, AA in Life Sciences or other health related field, Critical care experience desirable, Nephrology experience desirable, Cardiac experience desirable, Willing to pursue CCRC or CCRP certification
What You'll Do.
Collect clinical research data
Compile clinical research data
Document clinical research data
Analyze clinical research data
Use medical record as source
Negotiate differing priorities
Balance multiple tasks
Balance multiple timelines
Ensure studies are conducted per policies
Ensure studies are conducted per regulations
Practice cost containment
Ensure appropriate subject enrollment
Assist with data collection guidelines
Coordinate data collection procedures
Implement data collection processes
Coordinate study subject care
Protect subject rights
Protect subject well-being
Educate subjects on study process
Develop monitoring processes
Evaluate subject condition
Communicate concerns to PI
Document study subject activities
Maintain documents per HIPAA
Maintain documents per regulatory requirements
Implement study-specific quality goals
Implement study-specific quality practices
Oversee protocol compliance
Address adverse event issues
Act upon patient safety issues
Maintain study site integrity
Handle biological specimens safely
Procure study product
Administer study product
Participate in surveys
Participate in audits
Maintain integrity of medical records
Maintain integrity of administrative records
Maintain integrity of operational records
Troubleshoot protocol issues
Strategize with study participants
Assure quality study outcomes
Serve as contact between sponsor
Serve as contact between CRO
Serve as contact between PI
Serve as contact between clinical staff
Adhere to all regulatory practices
Coordinate logistics of activity
Participate in recruitment
Participate in interview process
Participate in education of new personnel
Educate new clinical staff on responsibilities
Maintain mandatory training requirements
Oversee performance of delegated activities
Resolve conflicting patient care protocols
Ensure research activities are not inappropriately billed
Ensure research activities are not illegally billed
Ensure research activities are minimally disruptive
Track study site education funds
Assist with disbursement of funds
Facilitate positive relationships with Medical Director
Facilitate positive relationships with management
Support physicians by communicating initiatives
Support physicians by communicating policies
Ensure physician notification of patient participation
Provide study documentation to Governing Body
Provide study documentation to clinic staff
Maintain up-to-date knowledge of equipment
Maintain up-to-date knowledge of technology
Implement study procedures around dialysis machines
Implement study procedures around dialysis process
Provide information on projected regional costs
Provide information on projected enrollment capabilities
Provide information on anticipated risks
Provide information on anticipated benefits
Provide information on logistical impediments
Ensure study enrollment goals are met
Ensure study resources are used efficiently
Ensure study budget is adhered to
Complete clinical trials management system
Complete electronic case report forms
Complete paper case report forms
Ensure maintenance of study subject payment records
Complete application documents
Coordinate ongoing document processing
Respond to mentoring inquiries
Complete study subject records
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Coordinate with PI; Coordinate with clinical staff; Coordinate with sponsor; Coordinate with CRO; Collaborate with management; Collaborate with physicians; Collaborate with facility manager; Collaborate with clinic staff
Communication Scope
Communicate concerns; Communicate initiatives; Communicate policies
Process & Methodology
Study timelines, Study protocols
Full Job Description
* **Must be comfortable with 50% travel.** * **Highly prefer someone who lives in the Northeast, as they will be traveling to Michigan, Mississippi, Louisiana, Indiana and New Jersey.** **_PURPOSE AND SCOPE:_** Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines. Performs a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject’s medical record as source. Negotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulations. Ensures research 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. Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies. _PRINCIPAL DUTIES AND RESPONSIBILITIES:_ * Assists with the determination of the guidelines for the collection of clinical data and coordinates and implements procedures and processes for data collection. * Coordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol and Principal Investigator (PI) delegation. * Protect the rights and the well-being of subjects enrolled in studies. * Ensures thorough, individualized, protocol-based study subject education on all study process requirements including but not limited to: informed consent, study participation obligations, appropriate use of investigational product, safety, privacy, rights and responsibilities. * Develops processes for methodically monitoring the status of study subjects as they progress through the study’s timeline of activities. * Regularly evaluates the study subjects’ condition and communicates/documents concerns to PI to ensure subject safety. * Accu
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