Clinical Research Coordinator (31205)
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GI Alliance
Germantown, MD (In Person)
Full-Time
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Job Description
Clinical Research Coordinator (31205)
Job Details Job Location:
Urology Conrad Pearson Germantown - Germantown, TN 38138Position Type:
Full Time Job Shift:
Day Description DescriptionPOSITION 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
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