At NSF International, our mission is to protect and improve human health. We're a global leader in standards development, testing, auditing, certification and training. We provide these services for a diverse set of industries including food, water, healOur nearly 3,000 employees provide services in over 170 countries through our many global offices, at our client sites, from home offices and in state-of-the-art laboratories. We're growing fast, and that's where you come in. Come join our team.The Clinical Data Associate I provides administrative support to the Clinical Department and assists in conduct of monitoring visits to ensure compliance with protocol, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), local regulations, applicable Standard Operating Procedures (SOPs) and project-specific requirements.
Key Duties and Responsibilities:
Assist in managing multiple sites within one or more protocols to assure compliance with protocols, project plans, and GCP guidelines
Assist in conduct on-site visits as required; pre-study, initiation, interim, and closeout visits
Complete and submit monitoring reports
File monitoring reports, confirmation and follow-up letters according to Amarex SOPs and/or Sponsor requirements along with Amarex quality standards
Coordinate, schedule and participate in internal and external meetings. Prepare, write and distribute meeting agendas and minutes
Assist in the training of investigators and study coordinators
Monitor site screening and study enrollment rates at each site and assist sites with implementation of techniques to maximize enrollment rates as necessary
Maintain close communication with clinical sites and serve as primary point of contact to ensure adherence to protocol and regulatory requirements
Participate in project team meetings and communicate in a timely and effective manner, with the appropriate internal or external individuals involved in the project
Assure that regulatory and other required documents are complete, accurate, maintained and approved in accordance with required regulations, guidelines, and SOPs
Assist with auditing of study files and retrieval of outstanding documents, as needed
Review source documents and Case Report Forms (CRFs) to assure timely, accurate, and quality data retrieval
Collect CRFs and other study-related supporting documentation (e.g., IRB approvals and renewals, correspondence, etc.)
Monitor Regulatory Binder and other study-related binders, as applicable
Monitors Investigational Product accountability
Basic financial tracking and invoice circulation
Monitor and support resolution of queries generated by Data Management
Contact and manage study vendors, as needed
Participate in the training and mentoring of Logistics Administrators (LAs), as requested
Other duties as assigned
REQUIRED EDUCATION AND EXPERIENCE:
Minimum of Bachelor's degree (or equivalent) in scientific discipline (degree in life science, biological science or any other healthcare field is preferred.)
2 years of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience). Prior experience in clinical research is preferred.
Working knowledge of ICH-GCP guidelines and FDA regulations
Strong verbal and written communication skills
Ability to work effectively both independently and in a team environment
Strong organizational and planning skills
Excellent interpersonal and professional skills
Excellent time management skills with the ability to prioritize responsibilities and multitask
Self motivated and detail oriented
Ability and willingness to travel > 70% of the time (domestic and international)
Proficient in Microsoft Office and able to learn appropriate software
