Perform management of project activities associated with monitoring functions of all phases of clinical research studies according to the Federal Code of Regulations, Good Clinical Practices, ICH Guidelines, local regulations, and SOPs and/or Sponsor SOPs.
Use critical thinking skills to monitor sites' compliance with study, sponsor, organizational, and regulatory guidelines. Collect, document, update, and report study information according to procedures and timelines. Create new and customize existing templates and processes to meet project needs with some direction. Follow up, resolve, and report on issues identified during study monitoring and assessment activities with minimal to no direction. Communicate effectively with site personnel, including the Principal Investigator (PI) to relay protocol/study deviations and ensure timely implementation of corrective actions
Perform site management, data review and cleaning. Assist with planning and development of the study set-up, execution, and oversight of clinical study.
WORK PERFORMED (Includes duties including but not limited to those listed below) • May travel up to 80% to perform on-site monitoring visits and co-monitoring visits, including site selection, initiation, periodic, and close out visits. • Independently perform monitoring activities for multiple sites and multiple projects, identifying and reporting deviations from regulations and SOPs. • Assess protocol and regulatory compliance, including but not limited to source document verification, informed consent process and human subject protection, data integrity, investigational product accountability and compliance, and review of investigator and regulatory files. • Provide study training and guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations. Identify subject safety and data integrity issues and retrain site personnel accordingly. • Identify action items and discuss with appropriate site personnel. Communicate to supervisor. Document ongoing follow-up and resolution of issues. • Assist sites with preparation for planned and unannounced audits with some guidance. • Provide review of study protocols. • May participate in the RFP process, including internal and external business development meetings. • Assist in conducting training sessions including investigator meetings, conferences, and team trainings.
• Assess adequacy of site personnel and facilities for study conduct. • Regularly review and update study and site status information and enter updates into required systems. • Independently generate monitoring reports, confirmation and follow-up letters. • Monitor, identify and notify the project team of emerging out of scope activities. • Review patient data and case report form data. Appropriately report safety concerns, protocol deviations and unexpected data trends. • Perform data review, including in-house CRF review, and alert project manager and data manager to emerging issues with CRF completion. • Review data status reports and follow-up with sites regarding missing and/or late data. • Provide training for site personnel on appropriate source documentation, CRF completion, data procedures and timelines, and query resolution. Review data queries, assist sites with query resolution and follow up on outstanding queries. • Maintain appropriate professional relationships utilizing an assertive, business-like manner which fosters study compliance. • Provide clear direction to site and trial personnel as directed while following project guidelines and professionally representing Paidion Research and our clients. • Communicate with project team to consolidate accurate and complete assessments of sites' activities keeping project team current on updates.
PEDIATRIC EXPERIENCE REQUIRED
• Bachelor’s degree in nursing, pharmacy or other allied health care discipline including appropriate certification/licensure (i.e., RN, RT, PA, or RPh), life science field (i.e., biology, chemistry, zoology, etc.) possessing a minimum of 3 years of directly related experience and extremely strong clinical knowledge. • Master’s degree or other post-graduate training in a clinical discipline or business/health care administration (e.g., MSN, PharmD, PhD, MD, MBA, MHA, MPH, etc.) acceptable for those candidates who possess a minimum of 1 year of directly related experience and extremely strong clinical knowledge.
• 2+ years of previous monitoring experience. • Must have current driving license. Valid passport required for those required to travel internationally • Proficiency in Microsoft Office Suite Software, CTMS, EDC, and eTMF. • Strongly prefer experience within pediatrics and in a variety of therapeutic areas. • Broad knowledge of drug/device development process. • Knowledgeable in clinical trial processes and systems applications to support operations. • Knowledgeable of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
3 openings. Telecommuting is allowed.
About Paidion Research
In the world of scientific inquiry, we're doing something completely different. Our name says it all: Paidion is the Greek word for children, little ones. They're why we're here: Our entire clinical research focus is exclusively on children. A global CRO (clinical research organization), we live our mission of using clinical research to improve the health of children around the world by helping companies and organizations develop clinical trials for kids. That's it...our passion, our expertise, our business, are all about–and only for–children.
Specializing in NICU and PICU populations. Because children respond to medical treatments differently than adults, pediatric clinical trials should be different from adult trials. It’s just good science: for optimum safety and efficacy, trial design and execution should match the physiology and needs of the patient population, especially children. Paidion combines pediatric clinical pharmacology expertise with innovative pediatric regulatory strategies and trial methodologies to provide best-in-class service to our drug development partners. Our experienced team provides a deep and broad understanding of practice norms and patterns, pati...ent procedures, standard drug use, and expected complications of related ages/gestational ages.
We’ve all heard the saying, “Children are not little adults.” Never was this truer than in the clinical research realm. Special considerations for this dynamic and vulnerable patient population must be taken into account in the development and execution of pediatric studies. Key to success are factors including physiological differences, safe and effective drug formulations and dosing, operational logistics that account for families, and the real life challenges of enrollment, compliance and overall quality.