Senior Clinical Research Associate (South East)

Posted Yesterday
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Hiring Remotely in Jacksonville, FL, USA
In-Office or Remote
Senior level
Biotech • Pharmaceutical
The Role
The Senior Clinical Research Associate conducts monitoring visits, ensures investigators meet study requirements, trains site staff, and participates in mentoring new staff.
Summary Generated by Built In
Company Description

Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.   

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia  

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.   

We have nourished a true international culture here at Ergomed.   

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.  

Come and join us in this exciting journey to make a positive impact in patient’s lives.   

Job Description

  • Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study 
  • Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period. 
  • Trains investigational site staff as necessary 
  • When applicable, supports preparation of regulatory and / or EC submissions 
  • Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance. 

 

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience 
  • Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials in oncology or rare disease 
  • Full working proficiency in English 
  • Ability to plan, multitask and work in a dynamic team environment 
  • Communication, collaboration, and problem-solving skills 
  • Ability to travel nationally 

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.   

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.  

 We offer:  

  • Training and career development opportunities internally   

  • Strong emphasis on personal and professional growth  

  • Friendly, supportive working environment  

  • Opportunity to work with colleagues based all over the world, with English as the company language  

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!   

Quality  

Integrity & Trust   

Drive & Passion   

Agility & Responsiveness   

Belonging  

Collaborative Partnerships   

We look forward to welcoming your application. 

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The Company
HQ: Raleigh, NC
535 Employees
Year Founded: 1997

What We Do

Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology. • 1,400+ highly qualified professionals • Global full-service CRO • 25+ years of experience • Therapeutic specialization in oncology • Strong expertise in rare disease trials • Robust clinical safety system • Choice of leading drug safety databases Our key services include: • Clinical Research Services • Pharmacovigilance • Medical Information • Regulatory • Medical Writing • Site Management • Study Physician Support • Biostatistics • Patient Study Support

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