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.

Responsibilities

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.

Recruitment/Enrollment/Retention

  • 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.

Communication

  • 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.

Data Management

  • 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.

Education

  • 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

Required:

  • 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

Preferred:

  • 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