CRA I or CRA II (with Monitoring Experience) – FSP – Turkey

Description

CRA I or CRA II – FSP – Turkey

(Previous CRA & Monitoring experience is a must)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. 

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

• Perform monitoring visits according to plan, document actions and follow up on action plans
• Site feasibility visits including analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies
• Train and guide site staff in the protocol and trial procedures to minimize protocol deviations (PDs)
• Train site staff in safety information handling and systems
• Know and meet all local and company requirements with respect to safety reporting
• Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
• Identify potential risks and proactively take action to prevent or mitigate
• Collaborate with data management/logistics in resolving queries
• Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
• Manage trial product requirements, including temperature deviations and training of site staff
• Motivate and build strong relations with site personnel to ensure the sponsor is their preferred clinical research partner
• Ensure collaboration with and deliverables from vendors locally, if applicable
• Collection and management of essential documents
• Support the site in filing and archiving trial documentation in the Investigator Trial

Master File (ITMF)

• Participation in Investigators meetings to ensure relations with sites as well as active presentation as applicable

Qualifications

What we’re looking for

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• 6 Months or more of clinical monitoring experience as a CRA 
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Fluency in English
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

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.

#LI-KU1

Read Full Description