Clinical Research Associate II/Sr CRA

Clinical Research Associate II/Sr CRA Job Description

At Pharmiweb, we are seeking a highly skilled Clinical Research Associate II/Sr CRA to join our team. As a Clinical Research Associate II/Sr CRA, you will be responsible for ensuring regulatory compliance and protocol adherence in clinical trials. Your expertise will be crucial in evaluating site performance and providing recommendations for site-specific actions. You will also be responsible for maintaining a working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes.

Key Responsibilities:

• Ensure regulatory compliance and protocol adherence in clinical trials.
• Evaluate site performance and provide recommendations for site-specific actions.
• Maintain a working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes.
• Verify informed consent processes and protect subject/patient confidentiality.
• Conduct monitoring activities, including on-site and remote monitoring, as per the Clinical Monitoring/Study Monitoring Plan.
• Manage reporting of protocol deviations and follow-up actions.
• Apply query resolution techniques and provide guidance to site staff as necessary.
• Perform investigational product inventory, reconciliation, and reviews storage and security.
• Act as primary liaison with study site personnel and ensure site personnel are trained and compliant with applicable requirements.
• Document activities via follow-up letters, monitoring reports, communication logs, and other required project documents.

Qualifications:

We are looking for a candidate with a Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience. You should have knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Excellent communication, presentation, and interpersonal skills are essential. Ability to manage required travel of up to 75% on a regular basis is also required.

About Pharmiweb:

Pharmiweb is a leading biopharmaceutical solutions organization. We are committed to accelerating customer success and translating unique clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model brings the customer and the patient to the center of everything we do. We are continuously looking for ways to simplify and streamline our work to make us easier to work with and for.

Why Join Us:

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. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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