Clinical Research Coordinator IV

PURPOSE AND SCOPE: 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.

PRINCIPAL DUTIES AND 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

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.

· This job operates in an office setting. While performing the duties of this job, the employee is regularly required to talk and hear. This role routinely and frequently uses a desk and standard office equipment such as computers, phones, and photocopiers with repetitive motion

· Physical effort required. Employee must be able to lift and carry up to 30 pounds

· This position does involve direct contact with patients and includes performing phlebotomy procedures, as needed. Occupational Health and Safety Risks include potential exposure to blood borne and airborne pathogens.

· The position requires 25% travel between assigned facilities and various locations within the community. Travel to regional, Sponsor locations, Business Unit and Corporate meetings may be required

· This is a salaried position; 40 hours weekly or as business needs dictate

SUPERVISION:

· None

EDUCATION AND REQUIRED CREDENTIALS:

· Bachelor’s Degree; Advanced Degree preferred or an equivalent combination of education and experience

EXPERIENCE AND SKILLS:

· 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

· 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

· 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

· Training/experience in management or other leadership roles is desirable

· Demonstrates excellence in leadership, autonomy, flexibility, self-direction, integrity, team building and mentoring capabilities

· Ability to work independently, and exhibit diplomacy and problem-solving skills in the performance of this role