Clinical Research Compliance Specialist

Job Title: Protocol Compliance Coordinator

Job Summary:

We are seeking a detail-oriented and organized Protocol Compliance Coordinator to join our team. In this role, you will be responsible for coordinating the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data.

Key Responsibilities:

• Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data;
• Tracks all necessary data and generates reports for the client, project team and/or external vendors;
• Represents the coordination team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the project team, coordinating all logistical aspects and assisting with facilitation;
• Interfaces with various internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals;
• Compiles adjudication dossiers and creates/submits follow-up to investigative sites;
• Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams;
• Manages project specific training and the set-up, maintenance and archival of program files; ensuring compliance remains audit ready;
• Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the Data Privacy team;
• Performs data entry into internal/external databases, tracking systems and budget management system; performs system reconciliations to identify issues which may negatively impact project timelines;
• Oversees expenses and manages translations; ensuring parameters are not exceeded;
• Answers incoming hotline calls, coordinates department functions and performs other duties as assigned;
• Supports any specific activities performed by the local office, which cannot be performed from elsewhere;
• Provides training to junior staff.

Requirements:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification;
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years);
• Knowledge, skills and abilities:
• Strong problem solving skills;
• Ability to work independently with minimal supervision, demonstrating initiative;
• Ability to build strong relationships;
• Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency;
• Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff;
• Self-motivated, positive attitude with effective oral and written communication and interpersonal skills;
• Excellent computer skills to include: MS Office (Word, Excel, PowerPoint, Access);
• Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines;
• Strong attention to detail and accuracy with orientation toward careful and meticulous work;
• Ability to maintain a positive and professional demeanor in challenging circumstances;
• Flexibility to reprioritize workload to meet changing project timelines;
• Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout.

Work Environment:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner;
• Able to work upright and stationary for typical working hours;
• Ability to use and learn standard office equipment and technology with proficiency;
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities;
• May require travel.