Clinical Research Coordinator II (31515)

JOB TITLE: Clinical Research Coordinator II
FSLA STATUS: Exempt
POSITION SUMMARY:
Experienced Research Coordinator that builds and leads a newly growing research department. Will have the opportunity to help create a premier research facility. Will be provided with the necessary support, budget, staff, etc. This position works closely with PI and Sub-Is on the various studies. Will be working in highly motivated large private practice urology group.

JOB RELATIONSHIPS:
• Reports to the Clinical Research Director, Vice President of Research, Market President, and the physicians at the local Market Clinic
• Collaborates with experienced patient navigators, IT, and data management.

ROLE QUALIFICATIONS: (experience, education, and skills)
• Able to handle a high volume of coordinating work, including managing multiple studies at a time of varying indications.
• Acts as an experienced resource for Clinical Research Coordinators I and Research Assistants during new hire training, newly initiated trials, and trial transitions.
• Demonstrate the ability to successfully oversee complex trials.
• Demonstrate the ability to understand and navigate Urology Austin and the various roles of stakeholders to ensure continuity of patient care.
• Must have knowledge of and experience with relevant federal and state regulatory guidelines.
• Must have > 2 yrs previous experience conducting clinical trials.
• Urology based clinical experience preferred. Willingness to perform urology required procedures to conduct urology research.
• Experience with evaluating and implementing study protocols.
• Certification via ACRP or the equivalent preferred.
• Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
• Effective time management and the ability to prioritize work.
• Excellent communication skills and the ability to interact with all levels of management, staff, and physicians.

ESSENTIAL JOB RESPONSIBLITIES:
• Leads the recruitment of studies, protocol conduction, and communication with study sponsors.
• Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
• Obtain and maintain consent of patients with the highest ethical standards.
• Work directly with patients to conduct all study visits. Ex: screen, consent, take medical history, complete necessary procedures including EKG, blood draw, vitals, etc.
• Communicate with and support patients end to end during trial participation and their families as necessary.
• Work with the EMR and data management systems to complete all data and source requirements for visits.
• Must have or gain knowledge of relevant software/programs, including the CTMS.
• Have a basic and working knowledge of trial design, statistical methods, etc.
• Triage, record, and report adverse events. Record and report any protocol deviations.
• Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls.
• Directly work with the Regional Manager and Research Director to assist overseeing all daily operations and implementation of policies and procedures in the department.
• Maintain HIPAA compliant communication and confidentiality, at all times.
• Participate in site visits, SIVs, monitoring, etc.
• Complete necessary study close-out steps and documentation.
• Conduct blood draws and laboratory procedures as required per study.
• Manage IP accountability and perform drug dosing and instillations per study requirements.
• Assist with other duties assigned.

PERFORMANCE REQUIREMENTS:

Knowledge
• Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices.
• Understanding of medical terminology.

Skills
• Ability to use multi-line phone systems and basic computer systems.
• Interpersonal and communication both with internal staff and external customers.
• Skill in reading medical chart terminology.
• Time Management.
• Phlebotomy.
• Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
• Elicit appropriate information for patients to clinic staff.
• Ability to read and understand information and ideas presented in writing.
• Ability to apply general rules to specific problems to produce answers that make sense - deductive reasoning.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:
The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:
• Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.
• Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.