LOCATION: Springdale, AR
DEPARTMENT: Clinical Research & Regulatory Affairs
SUPERVISOR’S TITLE: Chief Operating Officer
TOTAL NUMBER OF FTEs DIRECTLY OR INDIRECTLY SUPERVISED: 0
PURPOSE OF POSITION: To participate in the coordination, conduct & analysis of complex clinical research studies & to apply knowledge & experience with diverse study subjects to demonstrate proficiency in clinical research skills, problem-solving & priority setting. To serve as a resource within the department and the company.
Study Conduct/ Clinical Research Practice:
- Serve as a resource for all aspects of conducting a clinical trial for complex and multi-center trials.
- Perform studies under the guidance of a manager.
- Collaborate effectively with others to ensure proper progress & completion of studies.
- Assist colleagues by educating, providing resources, & consulting on difficult protocols or projects.
- Provide oversight and guidance as needed to research staff.
- Collaborate on multiple projects or studies.
- Collect specimens to meet study requirements.
- Execute participant compensation as per department policy.
- Work with other departments as needed to ensure proper handling, processing, storage and tracking of specimens per study requirements.
Regulatory Compliance and Documentation
- Perform regulatory activities & periodic internal self-audit of records.
- Prepare, review, submit and maintain regulatory activities/submissions; ensure accuracy and timeliness.
- Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.
- Apply federal regulations; state and local law; and company and department standard operating procedures (SOPs) to promote ethical practices in research involving human participants and to ensure compliance to those regulations.
- Document regulatory activities in appropriate systems.
- Coordinate and maintain up-to-date and accurate written and electronic records and files. -Develop and maintain regulatory binders.
- Prepare study staff for recruitment/enrollment for medium to large/complex complexity projects.
- Oversee study staff performance.
- Perform consent as needed.
- Proactively take initiative to ensure recruitment stays on track with the project timelines.
- Execute plan to identify potential participants.
- Engage study staff to assist in identifying and enrolling participants.
- Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them.
- Determine best method/s to identify potential participants for research protocol (advertisements, monitoring of clinic schedule, etc.) and prepare accordingly.
- Maintain a detailed tracking system for participants considered for enrollment. -Track progress at regular intervals and report out to manager.
- Compose clear, precise and detailed correspondence.
- Document, organize and maintain all correspondence.
- Oversee and follow through on questions and issues that arise during study conduct.
- Serve as liaison to departments, regulatory agencies, physicians’ offices, city clinics, academic centers, and other organizations.
- Communicate study related issues to managers in a timely fashion.
- Develop a rapport with study participants.
- Perform data entry and validation to ensure accuracy, quality and compliance of data collection process.
- Distribute, collect, and store case report forms (CRFs), questionnaires, and study payment forms in consultation with manager.
- Support the data-management process for clinical research projects, including addressing data queries from management.
- Maintain and audit data, providing status and activity reports as required.
- Organize data to analyze, identify, and report trends. Review reports, tables, and listings.
- Assist in data analysis and maintain record keeping and data storage for clinical research studies.
- Maintain master database files for clinical research protocols.
- Prepare reports from studies of clinical research projects.
- Evaluate and resolve issues regarding contents of reports.
- Ensure quality of data submitted from study sites and assure timely submission of data.
- Oversee the processing of laboratory and other external data.
- Maintain study payment tracking system.
- Complete required training.
- Serve as a resource to team members.
- Assist manager in the development of presentations, abstracts, and manuscripts.
Skills & Competencies
- Prioritization: using time efficiently and productively; prioritizing multiple tasks properly to meet deadlines; recognizing time constraints and adjusting work schedule to address them.
- Analysis – Basic: analytical ability sufficient to evaluate data, make judgments and recommendations
- Problem Solving: ability to independently work through details of a problem to reach a positive solution
- Fluent in written and spoken English.
- Excellent verbal, written and interpersonal communication skills.
- Strong organizational and project management skills to handle projects independently.
- Demonstrates an independent work initiative, sound judgment, diplomacy, tact and professional demeanor
- Understanding and showing respect and appreciation for the uniqueness of all individuals; leveraging differences in others’ perspectives and ideas; appreciating cultural differences and adjusting one’s approach to successfully integrate with others who are different from oneself
- Degree in science, nursing or equivalent degree/experience.
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
- Proficient in Microsoft Excel AND Access
- Due to the nature of this position it may be required for the employee to travel approx 25%. Therefore, the employee will be required to possess a valid Driver’s license
- Associate’s degree AND 4 years related experience OR
- Bachelor’s degree AND 2 years related experience
- Spanish as a second language
- Experience with Medical Device clinical trials
- Previous experience in a Clinical Trial Coordinator role
- Previous clinical trial monitoring experience
- License: LPN, RN, CCRC
Note: H-1B visa sponsorship not available