Regulatory Assistant - (Clinical Research)

About Us:

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Hourly Rate: $20.00 - $21.50/hr (depending on education, experience, and skillset)

Schedule: Monday - Friday 08:00 AM - 04:30 PM

Job Summary:

Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies in accordance to site SOPs, ICH, GCP, and FDA guidelines.
SOPs (Standard Operating Procedures)
ICH (International Council for Harmonization)
GCP (Good Clinical Practices)
FDA (Food and Drug Administration) 

Essential Responsibilities and Duties:

• Complies with current protocols, site SOPs, GCPs, IRB (Institutional Review Board) and FDA guidelines.
• Uploads regulatory documents with RealTime eDOCs System and files is paper binders, as necessary.
• Prepares, obtains, organizes and maintains regulatory and training documents in various storage mediums.
• Tracks submissions and ensure timely filing of documents.
• Obtains CVs (Curriculum Vitae) of external Investigators and other contract personnel and their signatures for appropriate regulatory documents.
• Forwards revised copies of protocols, informed consents, and other pertinent study documents to appropriate staff.
• Assists in obtaining necessary signatures from investigators.
• Works closely with study sponsor/CRO and key clinical trial personnel on relevant regulatory document issues.
• Ensures Clinical Conductor regulatory information is current.
• Participates in team meetings and complies with training requirements.
• Assists sponsors/CRO’s as needed.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• Must be able to effectively communicate verbally and in writing.
• Minimum: High School graduate or equivalent.
• Minimum of 1 year of related experience in clinical research 
• Must be self-directed and able to work with minimal supervision.
• Able to take a flexible approach to shifting priorities.
• Motivated to work consistently in a fast-paced and rapidly changing environment.

Working Conditions

1. Indoor, Office environment.
2. Essential physical requirements include sitting, typing, standing, and walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. Ability to work overtime, weekends, and/or holidays as needed.
6. Ability to travel as needed.
7. Remote work arrangement depending on location.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.