Clinical Research Coordinator (31205) in Germantown, Tennessee at GI Alliance

Description

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. Clinical Research Coordinator II Updated 11.2025 Abilities

• Skill in reading medical chart terminology.

. • 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