Senior Clinical Research Associate - US

Job title: Senior Clinical Research Associate - US in Boston, MA at Optimapharm

Company: Optimapharm

Job description: Location: home-basedRemote preferred location: Texas, Florida, Arkansas, Oklahoma Who we are?Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients’ lives.Optimapharm’ s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators globally. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, and flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.Join our expanding Clinical Operations team in the US as a Senior CRA and play a vital role in transforming clinical research - delivering real impact for project sponsors and improving the lives of patients and families across the globe. What do we offer?

• Working in a successful company that’s growing and developing every day


• Company that supports life balance


• Company with healthy culture


• Working with a highly experienced team of clinical research professionals


• Competitive salary


• Competitive PTO entitlement


• Health insurance, including vision and dental plans, to meet your and your family's needs


• Comprehensive pension plan to maximize savings and prepare confidently for the future


• Employee engagement programs


• Well-being initiatives


• Training and development program


• Fast-paced career path progression

• University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree


• At least 3+ years of independent clinical trial monitoring experience


• High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research


• Computer proficiency is mandatory


• Ability to read, analyze, and interpret common scientific and technical journals


• Excellent verbal and written communication skills


• Very good interpersonal and negotiation skills


• Ability to work independently, pro-active


• Affinity to work effectively and efficiently in a matrix environment


• A current, valid driver’s license

• Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits


• Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements


• Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable


• Identifying and escalating potential risks and identifying retraining opportunities for site personnel


• Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution


• Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor


• Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable


• Administration of site payments in accordance with relevant project instructions

Expected salary: $50000 - 100000 per year

Location: Boston, MA

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