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