Clinical Research Coordinator

Paycom; Town of Germantown (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Paycom in Wisconsin is seeking an Experienced Research Coordinator to build and lead a growing research department within a private urology group. You will oversee recruitment, protocol conduction, and study coordination, working with PI, Sub-Is, and study sponsors.

The role requires FDA/GCP/ICH knowledge, regulatory diligence, and strong communication. Willingness to perform urology procedures and engage in data management and training.

Qualifications

• 2+ years of experience conducting clinical trials.
• Knowledge of FDA, GCP, ICH and federal/state regulations.

Responsibilities

• Lead recruitment of studies and protocol conduction, communicate with sponsors.
• Obtain and maintain patient consent with high ethical standards.
• Conduct study visits: screen, take history, procedures (EKG, blood draw, vitals).
• Use EMR and data management systems to complete data/source requirements.
• Coordinate with IRB, sponsors, PIs and Sub-Is; attend meetings and visits.
• Assist with trial close-out steps and documentation.
• Perform blood draws and laboratory procedures as required per study.

Skills

Communication

Time management

Multi-study coordination

Clinical trial oversight

Data management

Education

ACRP certification

Tools

CTMS

EMR

Microsoft Office

Job 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 ClinicCollaborates 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:KnowledgeKnowledge of health care field; medical practice clinical and administrative systems, departments, and practices.Understanding of medical terminology.SkillsAbility to use multi-line phone systems and basic computer systems.Interpersonal and communication both with internal staff and external customers.AbilitiesSkill 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.