For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance, and medical information services to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle. We have an exciting opportunity for an Clinical Research Associate (CRA). This person will play a key role in supporting the conduct of clinical studies for molecular in-vitro diagnostics (IVD). The CRA will conduct site monitoring visits following a hybrid monitoring model. This role has flexible working arrangements, with the option to work in the office or remotely. PRIMARY RESPONSIBILITIES: · Based on experience the candidate will conduct site co-monitoring or solo monitoring visits (pre-study, initiation, routine monitoring and closeout) per monitoring plan and applicable SOPs. Write comprehensive reports to reflect all activities executed during visits and maintain accurate and complete action item logs. · Site monitoring responsibilities will include assisting Sr CRAs and CTMs with training and overseeing cross-functional site personnel on study related procedures for the duration of the study. You will also have an opportunity to conduct refresher training for sites as required per clinical monitoring plan. · Assists with study start-up activities including but not limited to evaluation, selection, and activation of investigational sites for clinical studies. · Confirms qualifications of site and personnel, specifically the Investigator and Site Staff, as well as confirming suitable resources and facilities to properly conduct the study. · Tracks enrollment activities, maintain applicable spreadsheets for team collaboration, and develope contingency plans as needed, to ensure sites remain on track with enrollment commitments. · Extensive review of site Essential Documents (ED) within the Investigator Site File (ISF) for accuracy and completeness. Reconcile and ensure appropriate filing within the Trial Master File (TMF). · Escalates site issues to Sr CRAs and CTMs to ensure transparent and expedient communication between sites and study management. · Works with Sr CRA’s and CTM to ensure Investigator Agreements (IA) and budgets are executed for assigned study sites. · Assists with organizing IRB/EC submissions with follow through to ensure successful outcomes. · Ability to travel up to 70Qualified candidates must have: Associates degree plus 4 years of job related experience; BS degree preferred At least one (1) year of (CRA) monitoring experience in the pharma, IVD or CRO industry Experience with clinical trial information systems A thorough understanding of clinical processes as well as GCP and ICH guidelines Excellent communication, organizational skills, and attention to detail Excited to ‘wear many hats’ and self-motivated to take on new challenges Well organized and detail orientedWe celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
