Senior Clinical Research Associate (m/f/d) - UK

Optimapharm; London; Remote; GBP 35,000 - 55,000; Full time

Job summary

Join a dynamic and globally operating firm as a Senior Clinical Research Associate, where you will play a pivotal role in monitoring clinical trials and ensuring compliance. This position offers the chance to work with a highly experienced team, engage in international projects, and enjoy professional growth opportunities. As part of this innovative company, you'll be instrumental in delivering new therapies that improve and save lives. If you're passionate about clinical research and eager to make a difference, this role is perfect for you.

Benefits

Performance bonus

Training opportunities

Professional growth

Flexible working hours

Qualifications

• 2-3 years of independent clinical trial monitoring experience.
• Fluent in English with excellent communication skills.

Responsibilities

• Perform routine site visits including monitoring and closeout visits.
• Manage assigned sites and ensure compliance and enrolment.
• Negotiate study budgets and assist with site contracts.

Skills

Clinical trial monitoring

Knowledge of ICH GCP Guidelines

Communication skills

Interpersonal skills

Analytical skills

Proactive working

Education

University degree in medical or life sciences

Nursing education or relevant healthcare degree

Tools

Data management systems

Computer proficiency

Job description

Location: home-based

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.

We are looking for an experienced SeniorCRAto join ourteam in the UKand support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.

What do we offer?

• Working in a successful company that’s growing and changing every day
• Working with a highly experienced team of the clinical research professionals
• International projects andprofessional growth
• Performance bonus
• Training opportunities

Who are we looking for?

Qualifications andExperience

• University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
• At least2-3yearsof independent clinical trial monitoring experience
• High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
• Fluent in English, both, written and spoken
• 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

Yourresponsibilities

• 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 in English and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.