Clinical Research Associate and Study Manager

hace 5 días


Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. Our company is built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Job Responsibilities

This role is responsible for performing site qualification, site initiation, interim monitoring, site management activities and close-out visits. You will use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.

You will maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. You will verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.

Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

Additional Responsibilities

In addition to the primary responsibilities listed above, this role may also include identifying and communicating out of scope activities to Lead CRA/Project Manager. Proactively suggesting potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.

Qualifications

Bachelor's degree or RN in a related field or equivalent combination of education, training and experience. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

Must demonstrate good computer skills and be able to embrace new technologies. Excellent communication, presentation and interpersonal skills. Ability to manage required travel of up to 75% on a regular basis.

Benefits

We offer a competitive salary ranging from $80,000 to $110,000 per year, depending on location and experience. Additionally, we offer a comprehensive benefits package including health insurance, retirement plan, paid time off, and professional development opportunities.



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