Clinical Research Associate

Clinical Research Associate

The Clinical Research Associate for Clinical Operation will provide site monitoring and management oversight across multiple clinical research trials in support of development of Pharmaceutical's drug pipeline. This position will report to Associate Director of Clinical Operations and be responsible for operational support for clinical studies and related activities in accordance with company standard operating procedures, good clinical practice, and applicable regulatory requirements.

Job Responsibilities:

• Support project management oversight of Clinical Development activities for multiple domestic and international trials, including:
• Track study timelines;
• Review and track study budgets;
• Provide periodic updates on Clinical Development
• Gradually develop responsibilities for management of contract research organization (CROs) activities for clinical and data management
• Provide monitoring support, in some cases functioning as the primary site monitor.
• Assist in writing and review of protocols, amendments, and informed consent forms. Manage development of study-specific guidelines (Case Report Forms, Monitoring Plans, and Pharmacy Manuals, etc.)
• Collaborate with Quality Assurance Department in development of Clinical Development standard operating procedures (SOP).
• Perform investigative site training
• Review CRO, vendor, and internal SOPs to ensure consistency and proper delegation of responsibilities among study teams.
• Assist in development of vendor relationships with CROs, drug depots, country-specific laboratories, and other vendors, as needed.
• Provide internal support for site recruitment activities.
• Oversee Trial Master File maintenance and reconciliation.
• Provide support to Regulatory Department in regulatory activities including submissions, and review of regulatory documents.
• Ensure compliance with FDA regulations and ICH Good Clinical Practice guidelines, as well as country-specific guidelines.
• Ensure compliance with study-specific procedures.

Key Considerations:

• Collaborate in a cross-functional environment in a small biotechnology company to assist in the initiation and coordination of global clinical initiatives and strategies.
• A strong background as a clinical research associate (CRA), specifically site monitoring or, alternatively; a nursing background would be noteworthy, particularly if the candidate has worked as a nurse at a research site.
• A therapeutic background to complement our pipeline, i.e. Cardiovascular, Hematology, Oncology, Pulmonology.
• Well-versed in Good Clinical Practices, medical terminology, and standard study procedures.
• Experience with electronic data capture systems.
• Good quality background and experience with healthcare or pharmaceutical development is required.
• Must be driven to deliver quality results on time and in a highly ethical and professional manner;
• Candidate must be willing to travel internationally (up to 25-50%, potential more depending on enrollment).
• Great organizational and communication skills.
• Proficient in use of Microsoft Office applications.

Qualifications:

• Thorough knowledge of Good Clinical Practice, clinical trial design, regulatory processes, and global clinical development process.
• 3-5 years of investigative site monitoring or study coordinator/study nurse experience.
• Hands-on experience in data cleaning and analysis required.
• Proven ability to work independently, to lead a multidisciplinary trial team.
• Proven experience in developing effective relationships with key investigators.
• Ability to maintain effective working relationships with coworkers, managers, as well as investigative site personnel.

Education: Undergraduate Degree