Job description

Employer : Iowa Oncology Research Association

Position Description

Position Title: Administrative Office / Regulatory Assistant

Classification: Clinical Research Associate

Reports To: Administrator

Summary:

The primary responsibility of this position is organizing, planning and controlling the work flow for processing and distributing research base mailing materials and assisting the Regulatory Coordinator with all regulatory-related activities. In addition, the Administrative Office Assistant will maintain regulatory documents and organizational information. This position will be 80% remote, 20% in office.

Essential Duties and Responsibilities: include the following. Other duties may be assigned.

Communications:

Maintain cooperative relationship with co-workers, component hospital departmental staff, investigator medical office staff, affiliate member staff, research base contacts, and clinical research participants.

Answer telephone, screen calls, take messages, and provide information to appropriate staff.

IRB/Protocol Management:

Maintain updated protocol information as directed by Regulatory Coordinator.

Prepare and distribute protocol allocation lists.

Prepare protocol material for Institutional Review Boards:

Type new consents and make changes per addenda for ongoing studies.

Synthesize and summarize Adverse Event reports from various research bases.

Prepare IRB certification forms.

Prepare Continuing Review forms by making copies of application, consent, HIPAA authorization, and addendum summaries from past year. (If IORA has patients on a study, obtain total number and make copies of signed consents and HIPAA authorization forms.)

Type cover letter for IRB submission.

Process and submit IRB approval forms to appropriate regulatory agency:

Prepare final approved copies of consents for office files.

File IRB approval letters.

Maintain IRB logs.

Maintain copies of all required regulatory documents.

Maintain copies of all IRB communications.

Office Management:

Assist with design and edit IORA quarterly newsletter.

Update and maintain public and protected portions of the IORA web site.

Prepare and distribute membership mailings including dues notices.

Order and maintain office supplies.

Prepare and catalog patient charts and protocols for off-site storage.

Other:

Prepare biosketches, required tables and accrual numbers as assigned for NCI grant applications & reports.

Assist in internal quality assurance program and research base audits.

Complete other tasks, as directed by Administrator/Primary CRA.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Qualifications:

Education and/or Experience: Associate or Bachelor’s degree required. Medical and/or clinical research experience preferred. Medical terminology helpful. Computer experience in Database software; Internet software and Word Processing software preferred.

Behavioral Skills: Follows policies and procedures; Supports organization's goals and values; Prioritizes and plans work activities; Uses time efficiently; Maintains research patient/participant confidentiality.

Technical Skills: Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality and completes work in timely manner.

Written Communication: Writes clearly and informatively; Edits work for spelling and grammar; Able to read and interpret written information; Able to write reports and business correspondence.

Professionalism: Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

Safety and Security: Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.

Adaptability: Adapts to changes in the work environment; Manages competing demands; Able to deal with frequent change, delays, or unexpected events.

Attendance/Punctuality: Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.

Dependability: Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Completes tasks on time or notifies appropriate person with an alternate plan.

Physical Demands: 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 functions.

While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds.

Occasional overnight travel to research bases is required for training purposes and updates.

Work Environment: The noise level in the work environment is usually mild to moderate.

Job Type: Full-time

Pay: $37,526.76 - $95,782.86 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Work Location: One location

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