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.POSITION SUMMARY
The Sr. Clinical Research Associate (Sr. CRA) performs 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. The Sr. CRA works closely with the Clinical Project Manager and is responsible for assisting in planning and executing of clinical trials.

Key Duties and Responsibilities:

• Possess detailed and current knowledge of the study protocol, site monitoring plan, study manuals, GCP guidelines and Code of Federal Regulations and local country regulatory requirements


• Independently oversee and manage multiple sites within one or more protocols to assure compliance with protocols, project plans, and GCP guidelines


• Conduct on-site visits as required; pre-study, initiation, interim, and closeout visits and prepare visit reports


• 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


• Oversee site study start-up procedures, including Institutional Review Board (IRB) submissions and contract/budget negotiations


• Serve as primary point of contact for site questions related to study conduct issues and study progress


• Assist in development of Case Report Forms (CRFs)/Electronic Data Capture (EDC) and the preparation of study manuals, informed consent documents, regulatory binders, source document templates, and other study materials


• Participate in project team meetings and communicate in a timely and effective manner, with the appropriate internal or external individuals involved in the project


• Establish regular lines of communication in addition to administering study-related training to assigned sites


• Recommend processes that lead to timely and successful placement, completion and/or resolution of project tasks


• Support the development of a subject recruitment plan


• Assure that regulatory and other required documents are complete and accurate, and are maintained and approved in accordance with required regulations, guidelines, and SOPs


• Evaluate the quality and integrity of site practices and escalate quality issues, as necessary


• Review source documents and CRF data to assure timely, accurate, and quality data retrieval


• Interface with study team to resolve data queries in a timely manner


• Contact and manage study vendors


• Oversee the ordering, tracking, and managing IP and trial materials


• Participate in the training and mentoring of Logistics Administrators (LAs), Clinical Trial Associates (CTAs), Clinical Data Associates (CDAs), as requested


• Other duties as assigned

• Minimum of Bachelor's degree (or equivalent) in life science, biological science or any other healthcare field


• 5 years of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience)


• At least 3 years of monitoring experience in clinical trials is required.


• Recognized CRA Certification (ACRP or SOCRA) 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