Clinical Research Coordinator II - South Bend, IN - Fresenius Medical Care Holdings, Inc.

This position supports the Frenova Renal Research division of Fresenius Medical Care.

PURPOSE AND SCOPE:

Supports the conduct and management of a clinical study by facilitating and coordinating the daily study activities. 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), International Council for Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines. Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies. Complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal regulations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

General Administrative

• Adheres to Standard Operating Procedures (SOP), GCP, all regulatory practices as established by law, and company policies and procedures
• Continues to display a mastery of Clinical Coordinator I duties and responsibilities while maintaining mandatory training requirements such as GCP, Certified Clinical Research Coordinator (CCRC), International Air Transport Association (IATA), and other applicable certifications and licensure
• Coordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol and PI delegation
• Develops a knowledge and understanding of implementation, coordination, site management, and reporting of clinical research operations throughout the company
• Implements study-specific quality goals and practices
• Participates in/leads special process improvement projects
• Troubleshoots the study protocol, and strategizes with all participants at every level of the study to ensure quality study outcomes and data
• Facilitates positive relationships with clinic practice manager, dialysis facility Medical Director and other appropriate management
• Supports physicians by communicating initiatives, policies and procedures; ensures attending physician receives notifications of research subject’s participation
• Participates as needed in study related, internal, or State/Federal and audits
• Perform/instruct others in completion of study procedures as described in study protocols
• Participates in the recruitment and interview process of new research personnel as directed
• Provides training/education to new investigator site staff members on study-specific topics and requirements
• Assists in maintaining adherence to investigator site training requirements by auditing and maintaining training records
• Coordinates with dialysis facility or clinic practice manager to educate new clinical staff on study specific responsibilities and protocol tasks
• Completes applicable study start-up documents (e.g. internal, Institutional Review Board (IRB) site submission, sponsor required) and coordinates ongoing essential document processing throughout the entire study
• Assists research site with coverage planning related to staffing and scheduling for research projects
• Actively identifies and participates in training, education, and development activities to improve knowledge and performance to sustain and enhance professional development

Conduct of Research

• Serves as a liaison between the PI and the study sponsor or Contract Research Organization (CRO), adapting a protocol to the specific local environment
• Arranges and leads study-specific coordinator calls
• Collects and submits regulatory/ethics documentation as required by the FDA and other regulatory agencies governing the conduct of research
• Develops study-specific training tools, and procedures to familiarize patient care staff with research interventions and protocols
• In consultation with the PI, identifies and resolves potentially conflicting patient care treatment protocols involving the clinic and support staff
• Assists with the determination of the guidelines for the collection of clinical data and coordinates and implements procedures and processes for data collection
• Participates in the determination of eligible candidates for study participation, assuring participants full eligibility requirements are met and reviewed with the PI prior to enrollment
• Ensures study enrollment goals are met per contracted obligations
• Facilitates study resources efficiently
• Ensures thorough, 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
• Provides the clinic Governing Body and clinic staff with appropriate study documentation
• Maintains integrity of Fresenius Medical Care, practice and study-specific medical, administrative, and operational records

Financial Management

• Reviews monthly financial statements for accuracy and budget adherence
• Ensures the study budget is adhered to cover the cost of research at study sites
• Tracks and coordinates potential site study subject stipend disbursement
• Ensures appropriate billing charge documents are submitted for reimbursement
• Provides relevant information regarding the projected regional costs of treatments, projected enrollment capabilities, anticipated risks/benefits at specific study sites, logistical impediments, etc. for use in study contract and budget negotiations

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 25% 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.

EXPERIENCE AND REQUIRED SKILLS:

• Has successfully performed in the role of Clinical Research Coordinator I  or equivalent for 3+ years and demonstrated outstanding performance, obtaining certification or other industry credentials, and other job performance measures. .
• CCRC or CCRP certification required
• Current state licensure, if applicable.
• Possess superior communication skills, precise attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
• Must have a collaborative focus, flexibility, ability to work independently, excellent organization skills and proficiency in MS office

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.

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.