Job Title: Clinical Research Coordinator II

Location: One GI-Dayton

Reports To: Regional Director, Clinical Research 

Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study  associated activities and ensures that regulatory requirements are followed including  

adherence to the principles of good clinical practices (GCPs) and adequate human subject  protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with  regulatory standards, sponsor requirements, patient safety and confidentiality and high  

professional standards. 

FLSA: Non-Exempt 

Supervisory Responsibility: This position has no supervisory responsibilities 

Key Responsibilities 

• Administratively and clinically manage industry sponsored clinical trials. 
• Adhere to Research SOP’s, Good Clinical Practices, and the study protocols. 
• Assist in patient recruitment by performing detailed chart reviews and patient interviews.
• Discuss study protocols with patients and verify the informed consent documentation. 
• Review medical history of patients against inclusion/exclusion criteria of studies. 
• Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations. 
• Schedule all patient research visits and procedures consistent with protocol requirements. 
• Dispense study medication, collect vital signs, and perform ECGs. 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with  prescribed study protocol. 
• Complete and maintain case report forms per FDA guidelines and review them against the patient’s medical  record for completeness and accuracy. 
• Function in a clinical role by conducting clinical research studies.  
• Monitor patients and provide information to the medical staff and other staff members to assure optimal  outcomes. 
• Develop written concise research study information and/or tools to be used for the education of staff and  the recruitment of patients. 
• Maintain compliance of protocols and regulatory guidelines for studies performed in the research area. 
• Act as a resource for other staff members regarding investigational issues or guidelines. 
• Coordinate the availability and distribution of medications for patients in a timely manner. 
• Perform phlebotomy for lab work as required and completes all necessary forms. 
• Responsible for the education of patients in all aspects of the disease process and/or clinical study in which  the patient may be involved. 
• Plan and coordinate the initiation of research study protocols, and the establishment of operating policies  and procedures. 
• Assist the principal investigator, research team, and Regional Director with various administrative tasks associated with the  day-to-day operations of research studies and projects.
• Plan and coordinate with the research team and Regional Director the staffing of research studies, to include the recruitment  and administration of research support staff, as appropriate to the activity.  
• Plan, implement, and maintain data collection and analysis systems in support of the research protocol. 
• Monitor the progress of research activities; develop and maintain records of research activities, and prepare  periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory  bodies. 
• Facilitate assigned clinical trial from start to finish. 
• Screen participants for all studies independently.  
• Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct  of clinical research.  
• Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice;  determine when escalation is required.  
• Adhere to infection control/safety guidelines and confidentiality policies. 

Core Competencies 

• Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized

General 

• Adopt the Impact Research culture of respect, integrity and accountability that contribute to an internal environment  of teamwork and promote a positive brand image to our external customers. 
• Incorporate a leadership mindset to your role.  
• Comply with Impact Research procedures, policies, and regulations relevant to your role.  
• Successfully completes all Impact Research training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.) 
• Responsible for compliance with all regulatory requirements and/or guidelines. These  requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws. 
• Computer skills – good working knowledge of MS office. 
• Ability to communicate effectively with others, both verbally and in writing. 
• Proven ability to manage time, meet deadlines and prioritize. 
• Able to maintain standards and professionalism during periods of fluctuating workloads. 
• Provide professional service to direct customers of Impact Research in all interactions. 
• Build effective working relationships with other team members. 
• Manage daily tasks to ensure business needs are consistently met.
• Provide professional service to direct customers of One GI in all interactions.
• Build effective working relationships with other team members.
• Manage daily tasks to ensure business needs are consistently met. 

Education and Qualifications 

• High School Diploma or equivalent required. 
• Associate or Bachelor's degree preferred. 
• Three+ years previous experience in clinical research  for pharmaceutical phase II or III trials  required. 
• Previous GI trials experience preferred. 
• Clinical experience in an office or hospital setting.  
• Must maintain current licensure and/or certification.  
• Basic Life Support certification required.  
• Knowledge of medical terminology, anatomy, physiology, and pathophysiology.  
• Familiarity with health care systems, regulations, policies, and functions. 
• Understanding of clinical research documentation standards. 
• Knowledge of equipment, supplies, and materials needed for medical treatment. 
• Understanding of basic laboratory procedures including phlebotomy, preparation, and screening.
• Working knowledge of industry standards and regulatory requirements relevant to clinical drug trials.