Clinical Research Professional II

ARKANSAS CHILDRENS IS A TOBACCO FREE WORKPLACE. FLU VACCINES ARE REQUIRED. ARKANSAS CHILDRENS IS AN EQUAL OPPORTUNITY EMPLOYER. ALL QUALIFIED APPLICANTS WILL RECEIVE CONSIDERATION FOR EMPLOYMENT WITHOUT REGARD TO RACE, COLOR, RELIGION, SEX, SEXUAL ORIENTATION, GENDER IDENTITY OR EXPRESSION, NATIONAL ORIGIN, AGE, DISABILITY, PROTECTED VETERAN STATUS OR ANY OTHER CHARACTERISTIC PROTECTED BY FEDERAL, STATE, OR LOCAL LAWS.

This position has been designated as safety sensitive and cannot be filled by a candidate who is a current user of medical marijuana.

CURRENT EMPLOYEES: Please apply via the internal career site by logging into your Workday Account (https://www.myworkday.com/archildrens/) and search the "Find Jobs" report.

WORK SHIFT: Please see job description for details.

TIME TYPE: Full time

DEPARTMENT: CC033021 Neurology Clinical Research Operations

SUMMARY: Coordinates multiple research projects and clinical research programs. Serves as a resource for research study participants, families, other healthcare providers, and members of clinical research teams regarding aspects of clinical research. Maintains oversight for national benchmarking databases, selected clinical research studies, and performance improvement activities.

ADDITIONAL INFORMATION: Coordinates multiple research projects and clinical research programs. Serves as a resource for research study participants, families, other healthcare providers, and members of clinical research teams regarding aspects of clinical research. Maintains oversight for national benchmarking databases, selected clinical research studies, and performance improvement activities.

REQUIREMENTS:

• High school diploma or GED or equivalent
• Recommended Education: Bachelors degree in a related field of study
• Required Work Experience:
• High School Diploma/GED and 2 years of relevant experience, or 4 years of experience in lieu of a diploma/GED
• Recommended Work Experience: (no specific requirements listed)

RECOMMENDED CERTIFICATIONS:

• Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals
• Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates

DESCRIPTION

1. Assesses, develops, and revises research protocols and prepares materials for approval. Prepares/assists with initial contract reviews and confidentiality agreement review.
2. Prepares and negotiates study budgets. Tracks account activity, resolves discrepancies, works with ACRI to insure funds are collected per contract at study end and funds are disseminated per internal budget.
3. Facilitates inspections/audits. Develops QA schedule for projects, and performs QA activities, and develops improvement plans.
4. Delegates/assists with creation of flowcharts, source documents, and other study related materials. Manages collecting and recording subject data on case report forms process. Creates databases and manages data entry.
5. Leads others to use the clinical process and teaching/learning principles to provide subject/family education and develop education tools/materials.
6. Coordinates/collects requested data for sponsor review during site visits. Assists study monitor(s) in chart and case report form review. Maintains files and study documentation according to institutional and regulatory standards.
7. Provides oversight for the orientation/precepting program; leads training and monitors process of preceptors. Promotes Mentoring relationships and leads community teaching. Leads education of subjects and families.
8. Leads performance improvement and research activities.
9. Performs other duties as assigned.