Clinical Research Coordinator (Onsite)

Thank you for considering a career at Bon Secours!

Scheduled Weekly Hours:

40

Work Shift:

Days/Afternoons (United States of America)

Position Summary:  Research Coordinator is responsible for coordination of clinical trial patient data for follow-up and survival visits along with occasional laboratory collection and processing.

Minimum Required Qualifications

Education:  Bachelor’s or Associate Degree Required.

Experience: Minimum 2-years’ experience in an established clinical trial program preferred but not required. 2-4 years medical office experience may be substituted for clinical trial experience.

Licensure, Registration, or Certification:

            Degree required.

            SOCRA or ACRP encouraged.

            No licensure required.

Position Responsibilities

Essential Functions:

• Responsible for accurate and timely data collection, documentation entry and reporting, schedules and participates in monitoring and auditing activities for patients that are on follow-up and/or survival data status.
• Reports Serious Adverse Events (SAE) reports to various sponsor companies and/or FDA within regulation timelines for patients that on follow-up and/or survival status.
• Communicates with physicians, research staff and sites and sponsors to resolve data issues for patients that on follow-up and/or survival status.
• Complies and maintains documents needed for sponsor monitoring visits and NCI site audits.
• Processes and completes shipping of sponsor and NCI study laboratory kits per IATA standards.
• Management of laboratory kits and supplies for all trials along with organization of the areas where these supplies are stored.
• In collaboration with the physician, reviews patients for changes in conditions, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents findings per EDC guidelines for patients that on follow-up and/or survival status.

• Coordinates follow-up patient care in compliance with protocol requirements and good clinical practice.
• Participates in required training and education programs.
• Communicates with physician regarding study requirements and adverse event reporting.
• Demonstrates strong time management and organizational skills.

Other Functions:

• Ensures site research quality by practicing in compliance with Bon Secours St Francis Hospital Standard Operating Procedures, principles of Good Clinical Practice and applicable federal, state, and local regulations.
• Supports and adheres to the Bon Secours St Francis Hospital Compliance Program, to include the Code of Ethics and Business Standards.
• Adheres to St. Francis Health System rules, regulations, and policies.
• Performs other duties as assigned.  Assists and supports other departments when needed.
• Familiar with all policies and procedures of practice for the St. Francis Health system.
• Displays excellent verbal and written communication skills.
• Possesses knowledge of clinic and nursing structure standards/policies for help with assisting nursing staff with patient data.
• Demonstrates self-directed learning through completion of orientation requirements, and research continuing education programs.
• Possesses personable research skills relative to the research patient/family.

Patient Population Served:   Demonstrates competency to provide accurate research data for adolescents, adults, and geriatrics in the Oncology and Stem Cell patient population.

Physical Requirements: Constant prolonged, extensive, or considerable desk work.  Constant manual dexterity, visual and hearing acuity.  Frequent hearing, speech, and communication to nursing and research staff.  Frequently lifts up to 10 pounds; occasionally up to 30 pounds.  The employee is occasionally required to sit; climb or balance; reach with hands and arms; and stoop, kneel, crouch, or crawl.

Environmental Conditions:  Frequently exposed to infectious, contagious, or blood-borne diseases.  May be exposed to hazardous fumes, body fluids and tissues.

Working Conditions:  Frequently subject to long or irregular hours based on patient’s research schedule.  Frequently subject to varying and unpredictable stressful situations.  Frequently operates computer to communicate information and input research data per Sponsor requirements.  Frequently answers telephone.  Constant use of vision, frequently close-up reading.  Constant manual dexterity required, to include grasping, handling, reading,