Small ( independent) specialty practice in Greensboro, NC has an immediate opening for a full time Research Clinical Study Manager to join a dynamic team to work on important clinical research in Headache Medicine.
Seasoned Knowledge of:
Research industry Phase I – IV trials,
Clinical research procedures & recording of results,
Professional nursing theory & practice to give/evaluate patient care, medical equipment and instruments,
Computer systems and applications,
Organizational policies, procedures, and protocols,
Common safety hazards and universal precautions to establish a safe work environment.
Follows protocols and FDA guidelines regarding patient care during each clinical research trial.
Reviews results and provides continued education with providers & staff.
Responds to inquiries from industry monitors & supports monitor office visits.
Administers prescribed medications and treatments in accordance with nursing standards and protocol requirements.
Practices sterile technique and universal precautions.
Instruct patients in collection of samples and tests, and family (if warranted) regarding medications and treatment instructions.
Maintains/reviews patient records, charts, and other pertinent information.
Handles blood and body fluids and deals with infectious patients.
Observes, records, and reports patient's condition and reaction to drugs and treatments to providers.
Enhances professional growth and development through in-service meetings, educational programs and conferences, and participates in committees as requested.
Adheres to NC controlled substances regulations.
Promotes wellness by providing patient education materials.
Communicates provider advice/instructions to patient.
Provides a friendly, safe, timely, quality-driven environment responsive to patients' needs.
Supervises research department staff & coordinates delegation of department duties.
Highly desirable skills and experience include:
Excellent interpersonal skills and ability to “connect” with participants to help in successful patient recruitment, retention, study visits, and overall research coordination
Excellent networking skills in generating new and available future study trials for the practice
Stellar organizational skills with strong use of excel and other database systems for data collection/management and overall study organization
Regulatory experience, with ease in working with IRB and research regulatory oversite; ability to prepare regulatory & progress reports & maintain technical background for the effective & ethical conduct of research
Experience with electronic EMR systems and other online database management system
Meticulous attention to detail in coordinating study and in data management, ensuring research is conducted according to specified protocols
Ability to take responsibility for the organization of clinical research and the timely completion of tasks, keeping track of both daily tasks and longer-term responsibilities
Ability to function independently & help lead the research team
Ability to monitor & organize study budget & submit invoicing in a timely fashion
Reliability in following-through on all study related tasks
Commitment to the success of the study research and study team
Growth potential: ready to learn and grow
Additional Salary Information: Based on experience & background