Senior Clinical Research Associate - US

Optimapharm .•Dallas, TX

4d•Remote

About The Position

Optimapharm is a mid-sized, global Contract Research Organisation (CRO) specializing in Phase I–IV clinical studies, delivering Full-Service and Functional Service Provision (FSP) solutions. As their US Clinical Operations team grows, they are seeking a Senior CRA committed to clinical excellence, passionate about mentoring, and driven to help bring innovative treatments to patients faster. The role involves working on diverse and challenging studies, collaborating with international professionals, and contributing to a culture that supports continuous growth and recognizes expertise.

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.
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.