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 subjects 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:

Bachelors 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 CROs 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