CLINICAL TRIALS OF TEXAS, LLC
Job Description
Job Title: Regulatory Compliance Specialist I
Department: Regulatory & QA Compliance FLSA Classification: Exempt
I. PURPOSE: To create, maintain and coordinate regulatory documents and activities throughout all clinical research studies conducted by Clinical Trials of Texas, LLC (CTT) according to CTT SOPs and policies and procedures, applicable federal regulations/ICH Guidelines, Good Clinical Practices (GCPs) and in compliance with each sponsor’s and institutional review board’s (IRB) specific requirements. All responsibilities should be completed in accordance with CTT’s Mission Statement and Employee Manual.
II. JOB RELATIONSHIPS:
Reports To: Manager II, Regulatory & QA Compliance
Senior V.P., Operations
President /CEO
Workers Supervised: None
Interrelationships: Interact with CTT staff, representatives from pharmaceutical/device sponsors, IRBs, nursing and medical staff members of various clinics, hospitals and physicians’ offices with whom CTT works.
III. RESPONSIBILITIES:
A. The Regulatory Compliance Specialist is responsible for, but not limited to the following job duties: A. Represent CTT in a professional and courteous manner (verbal, written and in appearance) when interacting with CTT staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals and physicians’ offices;
B. Prepare, maintain and provide oversight to all research-related regulatory documents.
1. Populate and coordinate the entire process of initial regulatory documents’ submission to the IRB, sponsors and state or federal regulatory offices as necessary;
2. Compile study information and submit initial, continuing and final reports to the IRB and/or sponsor;
3. Prepare applicable submission forms and submit updated documents including but not limited to: Amendments, Addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s and informed consent documents;
4. Accurately file and maintain all necessary logs within the regulatory binder(s);
5. Assist in and manage the archival of clinical trial documents/records;
C. Prepare for monitoring visits and audits;
D. Manage and update full-time and contract employee Curricula Vitae and ensure copies of all current and applicable medical/nursing licenses, certifications and other required regulatory documents are on file;
E. Abide by all HIPAA regulations; F. Maintain confidentiality of sponsor and CTT trade secrets;
G. Create error free written documents and reports (e.g. cover letters, notes-to-file, memos, etc.);
H. Perform all duties in a time- and cost-effective manner;
I. Perform other tasks as required.
IV. PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:
A. Work is normally performed in a typical interior/office work environment;
B. Local travel required;
C. Monitor/Sponsor/IRB Customer Service;
D. Daily computer usage;
E. Occasional night and weekend work schedules;
F. Ability to properly lift up to 25 pounds and occasionally more than 25 pounds;
G. Ability to drive, and daily availability of an automobile.
V. MINIMUM REQUIREMENTS:
Education: Bachelor’s degree or equivalent experience.
Experience: A. Minimum of 1-3+ years’ experience within the field of clinical or biological research.
Knowledge and Skills:
A. Demonstrates core values & all skills set required;
B. Must be experienced with Microsoft office applications (Outlook, Word and Excel) as
well as internet-based applications;
C. Must be detail oriented, organized, self-motivated, be able to work independently and on
a team, and the ability to stay on task and meet deadlines; D. Must possess excellent interpersonal skills including written and verbal communications;
E. Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics and other employees;
F. Must have good critical thinking and problem-solving skills;
G. Must be professional, and have a strong work ethic;
H. Must have the ability to adapt and take on additional tasks as requested;
I. Ability to problem solve while working closely across departments;
J. Assists with key initiatives/process improvements in the department;
K. Assists with training company new hires;
L. Completes at least 80% of goals annually