Job Description

This position is responsible for managing and developing study documents that are used on clinical trials. It is also responsible for creating, submitting, and closing out studies that are submitted to the IRB.

• Assists in the development of study documents and study preparation prior to the start of a study.

• Engages with CRCs (Clinical Research Coordinators) and study P.I.s during study preparation to ensure documents and procedures are documented in accordance with the protocol, GCP, and company SOPs.

• Manages the status and required items needed for studies involving the IRB, not limited to study submissions, deviation / SAE reporting, and study closeout.

• Engages with clients (when applicable) during study preparation phase to ensure all necessary documents (safety letter, informed consent, etc.) are finalized prior to IRB submission.

• Assists in the review and/or development of new protocols, assessments, procedures, and technologies.

• Assist with the development and updating of SOPs, WI, and training material related to study paperwork creation and IRB management.

• Ensure compliance with regulations.

• Provides excellent customer service to clients, and maintains positive interaction with peers and supervisors.

• Adheres to internal standards, policies, and procedures.

• Performs other duties as assigned.

Qualifications

EDUCATION AND EXPERIENCE

• Bachelor’s Degree, preferable in science or equivalent degree - Strongly Preferred

• Minimum 1 years of experience in clinical research or clinical recruiting - Required

• Research organization, and/or prior project management experience - Required

• Ability to coordinate multiple projects at once - Required

• Ability to work independently, use time wisely and multi-task - Required

• Previous IRB experience and / or clinical research regulatory experience - Preferred

LICENSES / CERTIFICATIONS

• CCRC or CCRA Certification - Preferred

KNOWLEDGE / SKILLS / ABILITIES

• Language Skills: English
• Mathematical Skills: Intermediate
• Reasoning Skills/Abilities: Intermediate
• Computer Skills: Proficiency with Microsoft Office applications, including Outlook, Word and Excel.
• Strong attention to detail and organizational and interpersonal skills

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.