Skip to main content

This job has expired

CRA - Oncology - Portugal

Employer
Syneos Health
Location
Portugal (PT)
Salary
Competative
Start date
27 Oct 2020
Closing date
26 Nov 2020

View more

Job Details

Here at Syneos Health, we are currently recruiting for a CRA II/ Senior CRA I to be a part of our FSP 360 model, outsourced to one of our best clients based in Lisbon. The main therapeutic areas will be Immunology and Oncology. The contract will be on a fixed term basis with possibility of extension.


Why us?

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

JOB ROLE:

Monitors activities conducted by clinical investigative sites as they relate to Sponsor's clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.

The CRA II/Senior CRA I conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring sponsor's studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites.


MAIN RESPONSIBILITIES:


Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and sponsor's Standard Operating Procedures (SOPs) and business processes;

Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:

- Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas;
- Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put into place as needed to ensure compliance;
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel;
- Ensures safety and protection of study subjects through compliance with the study monitoring plan, sponsor's SOPs, ICH Guidelines, and applicable regulations;
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

Appropriately reports and escalates serious or outstanding issues to project team member(s) and/or ACOM/COM/ Sr COM as appropriate, as defined in the study monitoring plan;

Facilitates Quality Assurance Audit processes as indicated;

Ensures regulatory inspection readiness at assigned clinical sites;

Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline;

Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner;

Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met;

Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.   REQUIREMENTS:

Bachelor’s Degree required; medical/science/nursing background is preferred.

Proven, relevant clinically-related experience, of which 2 years are preferable in clinical research monitoring;

Previous experience in Immunology and Oncology interventional studies required;

Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.

Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.

Demonstrated strong site management and monitoring skills.

Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.

Good written and verbal communication skills. Written and verbal fluency in Portuguese and English.

Acute observational skills, analytical and conceptual capabilities.

Exhibits high degree of flexibility when facing changes in the work environment.

Attention to detail and strong interpersonal skills.


We have a comprehensive benefits package and offer highly competitive remuneration.


#LI-VC1

Disclaimer:

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.

Company

Learn more about this company

Visit this company’s hub to learn about their values, culture, and latest jobs.

Visit employer hub

Learn more about this company

Visit this company’s hub to learn about their values, culture, and latest jobs.

Visit employer hub

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert