is the research arm of HCA's global cancer enterprise. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture. Summary of Key Responsibilities:
Primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines.Duties and Responsibilities:
Duties include but are not limited to:
- Establishes and maintains a document management system for regulatory paper and electronic files
- Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP's) for format and content
- Maintains updated physician credentials for network participants and other critical documentation ensuring compliance
- Modifies and/or develops informed consent forms and updates and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA
- Organizes and coordinates IRB documentation for trials
- Provides initial review and triage of IND Safety Reports as delegated by the Principal Investigator, and perform subsequent processing of those Safety Notifications that meet the IRB reportable criteria
- Assists any internal or external audit team with any regulatory related issues
- Apprises Regulatory Affairs Manager and Network Management, if applicable, of all study and site-specific regulatory issues for guidance and follow through
- Archives study specific regulatory documentation and correspondence
- Attends network meetings, conference calls and monthly staff meetings as appropriate
- Participates in educational activities and programs
- Maintains strictest confidentiality
- Practices and adheres to the "Code of Conduct" philosophy and "Mission and Value Statement"
- During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
- Knowledge : A body of information needed to perform tasks; May be obtained through education, training or experience
- Knowledge of scientific and clinical research terminology is essential
- Knowledge of IRB, FDA and GCP guidelines required
- Skills: The proficiency to perform a certain task
- Skills in MS Office products including Outlook, Word, and Excel
- Abilities: An underlying, enduring trait useful for performing duties
- Ability to multi task and meet strict deadlines.
- Attention to details in a fast paced environment
- Strong interpersonal, communication, and organizational skills
Minimum Required: High School Diploma (GED)
Preferred: Bachelor's College Degree (4 yr program)Experience:
- Two years in healthcare, research or other science related field
- Safety experience in clinical research or other healthcare environment
- Direct regulatory affairs experience