Clinical Research Coordinator IV

Fresenius Medical Care•Denver, CO

About The Position

Works under the supervision of the Principal Investigator (PI) to support 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.

Requirements

Bachelor’s Degree; Advanced Degree preferred or an equivalent combination of education and experience
Has excelled in the role of Clinical Research Coordinator III or equivalent for 5+ years and demonstrated a mastery of the job role, outstanding performance, and exceptional job performance measures
Clinical research site experience required
Strong presentation and writing skills required
Clinical Research Coordinator certification (e.g., CCRC or CCRP) required
Current state licensure, if applicable
Excellent computer skills: Ability to adapt to various electronic systems; proficiency in Microsoft Office applications minimally
Excellent communication and organizational skills
Ability to work independently, and exhibit diplomacy and problem-solving skills in the performance of this role

Nice To Haves

Training/experience in management or other leadership roles is desirable
Possibly represent organization at industry events i.e., MAGI, Site conferences
Possibly represent organization with sponsors, CRO’s, bid defenses either in person or teleconference
Willingness to participate in industry articles or marketing materials representing the organization
Demonstrates excellence in leadership, autonomy, flexibility, self-direction, integrity, team building and mentoring capabilities

Responsibilities

General Administration
Continues to display mastery of Clinical Research Coordinator III duties and responsibilities
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
Displays mastery of the SMO (Site Management Organization) system and organizational levels
Comprehensive knowledge and understanding of implementation, coordination, site management, and reporting of clinical research operations throughout the company
Conduct of Research
Direct study-specific quality goals and practices
Maintains essential trial documents according to applicable HIPAA and regulatory requirements
Works with dialysis facility manager and/or clinic manager to master standard of care procedures to better advocate on behalf of site research capabilities
Acts as an expert on each assigned protocol/study, identifying nuances and considerations which may potentially hinder study recruitment or research operations
Under oversite of direct supervisor and PI, consults with sponsor, when required, as well as with applicable SMO site staff members prior to study start to avoid such hinderances
Under oversite of direct supervisor, provides training/feedback/ and assists in resolution of problems while working directly with Sponsor, monitor, and other SMO team members as necessary
Utilizes subject matter expertise and knowledge to organize and coordinate the collection of data, documentation and record keeping activities related to the assigned clinical research studies ensuring compliance with the pertinent protocol and regulatory requirements by promoting and practicing GCP
Serves as a resource and mentor to junior SMO staff
Coordinates with dialysis facility or clinic practice manager to educate and train new facility/clinic employees on study specific responsibilities and per protocol requirements
Conduct webinar training with other SMO locations on an as needed basis on how to perform Quality Assurance (QA) on subject charts
Assists SMO managerial team with training each SMO location on quality assurance program guidelines per the current Working Practice Guideline (WPG). Escalate issues to direct supervisor in a timely manner for resolution, as deemed necessary
Assists with various projects as assigned
Other duties as assigned
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