FOOT & ANKLE CENTER OF ILLINOIS CLINICAL RESEARCH

RESEARCH ASSISTANT JOB DESCRIPTION

Job Summary

The Clinical Trial/Research Assistant (CTA) is responsible for assisting the Clinical Research Coordinator (CRC) in all functional aspects of clinical research. Research assistant duties include the following: subject screening, administering informed consent, compilation and submission of data, phlebotomy and processing lab samples, monitoring of study compliance, maintenance of data submission system, submission of invoices and statements, maintaining accounting ledgers, and regulatory documents maintenance. CTA assists the CRC with implementing education strategies for physicians and staff regarding active and prospective protocols. Conducts sampling of patient charts for quality review.

The Clinical Research Assistant strives for quality outcomes and innovative practice in accordance with GCP guidelines. The Clinical Research Assistant ensures practice is in accordance with competency required for that area. This is done through participation in quality assurance or performance improvement initiatives. The Clinical Research Assistance provides care in a collaborative manner with other disciplines to ensure optimal, individualized patient care and outcomes.

Knowledge of regulatory requirements for FDA and GCP research guidelines. Understands the evolving research and development needs of the organization in order to establish and maintain an effective strategy and operation to build research program.

Responsibilities and Duties

Duties:

o Collect, Process and track regulatory documentation as required by the sponsor, FDA and other national regulatory authorities.

o Patient recruitment and visit scheduling, processing and completing patient records and completing patient visit assessment.

o CRF completion and electronic data entry.

o Collecting/preparing lab specimens.

o Create and maintain clinical study files/source documents.

o Adhere to standard operating procedures (SOPs).

o Must know SAE reporting.

o Coordinate clinical trials, set-up study specific procedures, screen patients, follow-up and manage data collection on patients involved in sponsored clinical trials.

o Prepare approval applications to the Investigational Review Board (IRB) or other governing agencies.

o Performs related responsibilities as required.

o Maintain subject confidentiality

o Oversee day to day operations, advertisement, recruitment, compliance and completion of clinical trials.

Qualifications and Skills

Certified /Licensed Medical Assistant /Allied Health Professional or Bachelor Degree in Biological Sciences with Phlebotomy Certification. BLS. Minimum of 1 year in clinical human research experience. Regulatory knowledge and maintenance. Minimum of 1 year experience handling biological samples. Basic office experience with ability to utilize computer programs including Word, Excel, PowerPoint, Outlook Express, and Quick Books preferred. Excellent oral and written communication skills. Able to work independently. Proficient in medical terminology. Above average communication skills and the ability to relate effectively to the public and health care professionals.

Benefits

Full benefits available with medical, dental, vision if needed. 401k available.

Job Type: Full-time

Pay: $35,000.00 - $50,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Experience:

Clinical trials: 1 year (Preferred)
Research: 1 year (Preferred)

Work Location: In person

Foot and Ankle Center of Illinois

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Clinical Research Assistant