Pharmacy Site Monitor (CRA I) - FSP client dedicated - Western Germany - home based
Job description
Description
Pharmacy Site Monitor (CRA I) - FSP client dedicated - Western Germany - home based
Here at Syneos Health we are currently recruiting for a Pharmacy Site Monitor (CRA I) opening, to work on a sponsor-dedicated role in the Western part of Germany, performing onsite monitoring visits in pharmacies around Düsseldorf, Köln, Mainz etc. and the surrounding area. It is a permanent, full-time, home-office position. The roles are part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting.
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- 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. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job responsibilities:
- Conducts Site Initiation visits in collaboration with RCO Site Managers and RCO Site Monitor where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
- Evaluates potential pharmacies to assist in the placement of planned clinical studies
- Critically reviews and analyzes pharmacy activities through on-site and off-site visits as per the monitoring plannd applicable client SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes, but is not limited to: - Manages multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Must understand and follow the monitoring methodology assigned to the study as per the SMP which may include Risk-Based monitoring, reduced Source Data Verification or 100% Source Data Verification.
- Ensures quality of data submitted from pharmacies and assures timely submission of data.
- Ensures safety and protection of study subjects according to the monitoring plan, client SOPs, and ICH and FDA GCP Guidelines and local regulations (i.e. HC).
- Monitors activities of pharmacy personnel to meet study objectives.
- Anticipates and proactively solves study pharmacy problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
- Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
- Appropriately escalates serious or outstanding issues to line manager and project team members.
- Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits for all pharmacy-related topics.
- Conducts Site Initiation visits in collaboration with RCO Site Managers and RCO Site Monitor where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
- Evaluates potential pharmacies to assist in the placement of planned clinical studies
- Critically reviews and analyzes pharmacy activities through on-site and off-site visits as per the monitoring plannd applicable client SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes, but is not limited to: - Manages multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Must understand and follow the monitoring methodology assigned to the study as per the SMP which may include Risk-Based monitoring, reduced Source Data Verification or 100% Source Data Verification.
- Ensures quality of data submitted from pharmacies and assures timely submission of data.
- Ensures safety and protection of study subjects according to the monitoring plan, client SOPs, and ICH and FDA GCP Guidelines and local regulations (i.e. HC).
- Monitors activities of pharmacy personnel to meet study objectives.
- Anticipates and proactively solves study pharmacy problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
- Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
- Appropriately escalates serious or outstanding issues to line manager and project team members.
- Facilitates the Regulatory Compliance audit process, as needed.
- Provides monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentors to other colleagues as assigned.
- Proactively communicates and escalates with all internal and external stakeholders any issues identified at pharmacies while developing the corresponding mitigation strategies and recommended approach.
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
- Interacts and builds professional and collaborative relationships with all study personnel (pharmacist), peers, and client office-based personnel.
- Uses multiple technologies to foster, maintain, and enhance open communication
Specification for unblinded monitoring activities (keeping the blind, reporting and communication)
Ensure that the following three main principals and drivers are met:
- Ensure IP is managed, stored, administered, disposed of and documented appropriately.
- Ensure that blinded personnel (client and site and subjects) remain blinded to patient randomization and treatment.
- Manage potentially unblinding documentation and communication of any issues that occur during the study.
Qualifications
- Min B.A./B.S. required with strong emphasis in science and/or biology coupled with relevant work experience, higher degrees are preferred. GCP/CRA certification is an additional advantage.
- Some previous experience in clinical research is required
- Fluent in German and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act appropriately
- Willingness to perform 6-8 onsite monitoring visits per month, within Germany
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
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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