CRA II / Sr CRA I (multisponsor) ** Homebased PORTUGAL ** Madeira

CRA II / Sr CRA I (multisponsor) ** Homebased PORTUGAL **
Madeira
Madeira, Madeira, Portugal

CRA II / Sr CRA I (multisponsor) ** Homebased PORTUGAL **

Updated: Yesterday

Location: Portugal-Europe - PRT-Home-Based

Job ID:25001692

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.

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.
• We are continuously building the company we all want to work for and our customers want to work with.

Job responsibilities;

• Performs site qualification, site initiation, interim monitoring, site management and
  - out visits (performed
  - site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
• Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP).
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Documents activities via confirmation letters,
  - up letters, trip reports, communication logs, and other required project documents.
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team.
• May act as primary liaison with project site personnel.
• Prepares for and attends Investigator Meetings and/or sponsor
  -
  - face meetings.
• Provides guidance at the site and project level towards audit readiness standards.
• May provide training or mentorship to more junior level CRAs.
• For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I.
• Additional responsibilities include site support throughout the study lifecycle from site identification through close out.

Qualifications

What we’re looking for;

• 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.

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
- changing environment.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.