Senior Clinical Research Associate - US

Optimapharm .•Las Vegas, NV

13h•Remote

About The Position

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. As we expand our US Clinical Operations team, we’re looking for a Senior CRA who is driven by excellence - a professional committed to responsible oversight, meaningful patient outcomes, and shaping the future of clinical research with purpose and precision.

Requirements

University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
At least 3-5 years of independent clinical trial monitoring experience in oncology
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

Responsibilities

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

Benefits

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