Location: RemoteAs our US Clinical Operations team continues to grow, we're looking for a
Senior CRA who is committed to clinical excellence, passionate about mentoring others, and driven by the opportunity to help bring innovative treatments to patients faster.
At Optimapharm, you'll work on diverse and challenging studies, collaborate with experienced professionals around the world, and play a critical role in shaping the success of clinical trials - all within a culture that supports continuous growth and recognizes expertise.
Who are we looking for? Qualifications and Experience - 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
Your 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
By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development. If you would be interested in joining the Optimapharm team, please
send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.
Compensation is competitive and final offers will reflect each candidate's experience, skills, and qualifications.
Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.
