Research Coordinator chez The Orthopaedic Institute

Description

JOB OVERVIEW: 

Manages quality controls and the execution of clinical protocol and data management for a number of clinical trials, ensuring compliance with all regulatory and contractual requirements. Establishes and maintains sound clinical and data collection practices to ensure validity of studies. Monitors the conduct and progress of the studies to ensure compliance with established protocols, appropriate research methodology, and study timelines. Participates in protocol development, site/investigator selection, study initiation and termination activities. Develops and completes final study reports. 

ESSENTIAL FUNCTIONS INCLUDE, BUT ARE NOT LIMITED TO: 

Clinic Duties

• Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines,      and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
• Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
• Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and      compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
• Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and      problems, and clarifies and/or obtains changes to data as appropriate.
• Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and      accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
• Performs miscellaneous job-related duties as assigned.
• Overseeing the trouble-free running of clinical trials
• Collecting data obtained from research, coding and analyzing it
• Managing budgets set aside for research
• Communicating with participants regarding study objectives
• Administering questionnaires and monitoring participants to ensure they adhere to the study’s rules
• Monitoring the study to ensure that it complies with protocols, is ethically-conducted and follows regulatory standards
• Maintaining research records of study activity, including case report forms, or other regulatory forms as per FDA guidelines

Requirements

QUALIFICATIONS/LICENSE: 

None

EDUCATION:

High School Diploma or equivalent

EXPERIENCE:

1-2 years of medical office experience preferred

SKILLS:

· Excellent customer service skills.

· Comfortable working in fast-paced environment.

· Excellent communication skills, both verbal and written.

· Proficient with computer skills including experience with practice management software desired. 

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function.

· Specific vision requirements include the ability to see at close range, distance vision, peripheral vision, depth perception, and the ability to adjust focus.

· While performing the duties of this job, the employee is regularly required to talk and hear.

· Possess the ability to fulfill any office activities normally expected in a direct patient care role in a medical office setting.

· Frequently required to stand, walk, sit, use hands to feel, and reach with hand and arms.

· Occasionally lift and/or move over 25 pounds.

· Fine hand manipulation (keyboarding).

· Travel may be required to existing or new TOI locations.