Under the direction of the Senior Project Manager the CRA has responsibility for the comprehensive monitoring of clinical study sites. This includes the responsibility to verify that the rights and well-being of human subjects are protected and that the trial is conducted in compliance with GCP and with all applicable regulatory requirements. The CRA will also assist with other project management and site management activities.
This is a Full Time position that will be based out of our New York City office when not traveling.
This is not a Contract position.
- Coordinate and manage clinical site monitoring responsibilities for assigned projects, with guidance from the Senior Project Manager.
- Perform clinical site monitoring duties in accordance with contractual agreements, department guidelines, SOPs, applicable international, Federal and State regulations, and ICH Guidelines.
- Serve as a liaison to internal and external partners and to the project core team (project leader, principal investigator, and other functional group key representatives).
- Oversee trial-related training and any performance concerns of the clinical trial sites. Maintain awareness of level of performance and training needs; provide ongoing input to the senior project manager for the development of individual training plans.
- Manage the development and maintenance of clinical trial documents, processes and systems according to trial-specific scope of work and budget, and possess the skills and leadership to perform these activities on an independent basis.
- Assess the suitability of potential investigative sites through telephone screening interviews, regulatory document review and evaluation of clinical trial information.
- Follow established study-specific guidelines for the collection of clinical data and/or administration of clinical trials.
- Conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of the principal investigator to conduct and complete the planned clinical study.
- Conduct site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, product accountability procedures, adverse event reporting, and overall site management.
- Conduct monitoring visits to ensure the compliance and the integrity of clinical data through review of CRFs, source documents, medical records, and regulatory documents.
- Track study site activities, including but not limited to:
- Screening and enrollment
- Collection and review of site essential documents for completeness
- Trial Master File Maintenance
- Study site progress and issues
- Ensure that adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP), is maintained via the documentation of all activities. Ensure that Standard Operating Procedures are followed, and that all aspects of the study activities are conducted in accordance with the ethical and professional standards and established policies of the Company
- Attend external and internal meetings such as vendor meetings and internal meetings
- Communicate with sites and sponsors through verbal and written correspondence, summarizing the overall site function, any deficiencies, and corrective action if needed. Follow-up with sites until deficiencies are resolved.
- Provide all job-related progress reports/technical reports as requested.
- Performs related duties as required and assigned.
- Work requires graduation from a 4 year accredited bachelor’s degree program.
- Required Knowledge, Skills and Abilities: knowledge of medical terminology, Federal regulations and ICH-GCP, time management and problem solving skills, and the research process.
- Must be able to work independently following a brief period of specific job related training.
- Must possess excellent verbal and written communication skills.
- Strong organizational skills with attention to detail.
- Must demonstrate basic computer proficiency.
- Demonstrate a high degree of personal and professional integrity.
- Willing to travel 50% or more depending on trial demands
Job Type: Full-time
Travel as required to accomplish responsibilities
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