Research Assistant - Onsite

POSITION SUMMARY

Responsible for supporting Orthopedic One Physician and research coordinator in clinical research activity. Research activity may be retrospective, prospective, physician or industry initiated, or device or pharmaceutical in nature. Follow ethical and legal research guidelines according to the Declaration of Helsinki, US FDA Regulations for pre, post and investigator research, and the ICH Tripartite Guideline on Clinical Safety Data Management.

RESPONSIBILITIES AND ACCOUNTABILITIES

Responsibilities/Accountabilities:

Facilitate clinical research studies conducted by principal investigator(s) including but not limited to collection, compilation and documentation of clinical research data. Coordinate the development of forms, questionnaires and the application of research techniques. Enroll patients in existing prospective databases and ongoing clinical trials while ensuring compliance through active monitoring. Utilize electronic medical records software to look up patient information and data collection, with proficiency in Excel for processing and querying data. Work with study coordinator and the IRB to ensure IRB paperwork is complete and appropriate updates are submitted. Assist with data collection for existing and new prospective and retrospective studies via direct patient contact in the clinic, electronically, or by telephone.

TEAMWORK

Teamwork:

Willingly provides coverage, volunteers assistance, and maintains workflows within department as needed without direct instruction/supervision. Works cooperatively and refrains from participating in negative conversations. Shares knowledge and insights with co-workers in a constructive manner. Works to solve problems and address conflicts with appropriate person directly before involving leadership or uninvolved peers. Is considerate of others in the work environment with regard to taking breaks or meal periods, use of computer and phone, noise level in the department, etc.

POLICIES AND PROCEDURES

Policies and Procedures Knows and complies with policies and procedures as enumerated in the Orthopedic One Employee Handbook and policies and procedures documents. Provides assistance and support to leadership in implementing policies and procedures as necessary. Actively participates in training, and conducting day to day work activity by adhering to all policies and procedures as enumerated in compliance and risk management programs.

QUALIFICATIONS

Education, Experience, Certification and Licensure Requirements:

Currently studying or completion of Life Science, Biology, Physiology or Nursing degree program. Experience in orthopedics and/or IDE research highly desirable. A command of the English language and various formatting techniques such as MLA is also required.

Location:

Orthopedic One •

Clinical Services Schedule:

Regular Full Time, Day Shift