Qureos Mentor

PSI CRO

<div>Company Description 
We are the company that cares &ndash; for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them. 
Job Description 
The Site Contract Specialist can be based anywhere in the United States.
The core responsibilities of this role include:<ul><li>
Facilitating negotiations of site agreements and budgets to ensure alignment with the site activation plan</li><li>
Customizing and preparing country- and site-specific agreements and organizing their translations</li><li>
Tracking the status of site agreement and budget negotiation</li><li>
Preparing executable versions of site agreements and budgets, and coordinating the signature process</li><li>
Filing executed site agreements in the Trial Master File</li><li>
Updating all concerned functions on the site contracting process</li></ul> 

Qualifications 
<ul><li>
College or university degree or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities. Equivalency is defined as a minimum of 2 years&rsquo; experience in an environment, where relevant experience has been gained.</li><li>
Minimum 1 year experience in the clinical research industry in the United States</li><li>
Knowledge of and experience with legal documents related to clinical trial sites and medical terminology is a plus.</li></ul> 

Additional Information 
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.</div>

Site Contract Specialist I

<div>Company Description 
PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. 
Job Description 
Take your career to the next level and be involved in study startup processes in T&uuml;rkiye. You will provide direct operational support to project teams, ensure that clinical projects start smoothly and on time and support PSI in developing the local study startup team.
Office-based in Ankara or remote<ul><li>
Perform study startup activities and support all processes critical for site activation.</li><li>
Collect site documents for IRB/IEC submission and/or IP-RED process.</li><li>
File study-specific documentation in TMF, in accordance with Document management plan.</li><li>
Compile IP-REDs packages assuring high quality.</li><li>
Review study-specific translations, including patient-facing documents.</li><li>
Support site agreement and/or budget negotiations, upon request.</li><li>
Ensure initial distribution of locally obtained clinical study supplies to sites and supervise initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.</li><li>
Identify project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.</li><li>
Develop site-specific startup timelines and is responsible for meeting the site activation targets under supervision.</li></ul> 

Qualifications 
<ul><li>
College/University degree or an equivalent combination of education, training and experience</li><li>
At least 4 years' experience in clinical research</li><li>
At least 3 years of full-scope Study Startup experience in T&uuml;rkiye</li><li>
Excellent knowledge of ICH GCP, local laws and applicable regulations in the region</li><li>
Full working proficiency in English and Turkish</li><li>
Communication and organizational skills</li><li>
Ability to negotiate and build relationships at all levels</li></ul> 

Additional Information 
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.</div>

Senior Study Startup Specialist

<div>
 
 Company Description
 
 
 
 We are the company that cares &ndash; for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
 
 
 
 Job Description
 
 
 
 We are in search of an experienced professional dedicated to developing strategic relationships with clinical research sites, with the aim of optimizing and advancing the progress of clinical trials.
 
 
 
 General Responsibilities:
 
 
 
 <ul>
 <li>
 Maintain and refine internal site databases in cooperation with Study Startup, Clinical Operations and Process Improvement
 </li>
 <li>
 Participate in the development and implementation of improvement strategies for the site identification process and related training activities
 
 
 
 </li>
 </ul>
 
 Project Responsibilities:
 
 
 
 <ul>
 <li>
 Define the main study objectives and the optimal site profile
 </li>
 <li>
 Create initial list of potential sites
 </li>
 <li>
 Communicate with project teams on project/ regional level to fine-tune strategy and methodology of initial and follow-up site contacts depending on indication, regional specifics, and technologies in use
 </li>
 <li>
 In cooperation with the project team, maintain a study site identification tracker for further site evaluation and selection activities
 </li>
 <li>
 Liaise with project teams to evaluate status and progress of site identification, to identify and highlight any potential risks or issues to timelines or objectives
 </li>
 <li>
 In cooperation with Legal, perform due diligence check of regulatory and legal limitations applicable to the recommended investigators or clinical sites
 </li>
 <li>
 Support the project team throughout study startup and further on, whenever additional rounds of site identification are necessary, and/or additional information on the site/investigator is needed
 
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 University/college degree (Life Sciences/Pharmacy/Healthcare field is a plus), or an equivalent combination of education, training and experience
 </li>
 <li>
 Minimum 2 years of prior experience in site identification/study startup activities or equivalent
 </li>
 <li>
 Full professional working proficiency in Turkish and English
 </li>
 <li>
 Understanding of Good Clinical Practice, local laws and applicable regulations in Turkey
 </li>
 <li>
 Communication and collaboration skills
 </li>
 <li>
 Demonstrated ability to work in a dynamic environment, under compressed deadlines across several projects, each with unique requirements
 
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 Take your career to a whole new level. Join a company committed to prioritizing its employees and dedicated to investing in their ongoing professional growth and success.
</div>

Site Identification Specialist (Feasibility)

Join PSI CRO and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

PSI CRO

ABOUT_COMPANY

Site Contract Specialist I

Senior Study Startup Specialist

Site Identification Specialist (Feasibility)