Optimapharm · 1 month ago
Senior Clinical Research Associate - US
United States
Full-time
Remote
Mid, Senior Level
3+ years expOptimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients’ lives. They are seeking a Senior Clinical Research Associate who is committed to responsible oversight and meaningful patient outcomes, with responsibilities including site visits, managing sites, and negotiating study budgets.
Pharmaceutical
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
Qualification
Required
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
Benefits
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
Company
Optimapharm
Optimapharm is a full-service Contract Research Organization that provides tailored solutions for clients.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
The Rohatyn Group
2020-05-13Private Equity
Leadership Team
Ivana Waller
Group CEO
Recent News
keyhavencapital.com
2024-01-05
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