CRA I Madrid. Sponsor dedicated.

Syneos Health Commercial Solutions

Dec 2

Applications are closed

Job
Full-time
Entry Level
Science
Healthcare
Madrid
Remote

Requirements

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

Responsibilities

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
For the Clinical Monitoring/Site Management Plan (CMP/SMP):
Assesses site processes
Conducts Source Document Review of appropriate site source documents and medical records
Verifies required clinical data entered in the case report form (CRF) is accurate and complete
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
Verifies site compliance with electronic data capture requirements
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.
May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:
Site support throughout the study lifecycle from site identification through close-out
Knowledge of local requirements for real world late phase study designs
Chart Abstraction activities and data collection
Collaboration with Sponsor affiliates, medical science liaisons and local country staff

FAQs

What is the job title for this position?

The job title is Clinical Research Associate I (CRA I) based in Madrid.

What are the main responsibilities of a CRA I?

The main responsibilities include site qualification, site initiation, interim monitoring, site management activities, close-out visits, ensuring compliance with regulatory guidelines, and supporting subject recruitment and retention strategies.

What qualifications are required for this position?

A Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience is required.

Is travel required for this position?

Yes, the position requires managing travel of up to 75% on a regular basis.

What skills are necessary for a CRA I at Syneos Health?

The necessary skills include a good understanding of Good Clinical Practice/ICH Guidelines, excellent communication, presentation, interpersonal skills, and proficiency in computer skills and new technologies.

What is the culture like at Syneos Health?

Syneos Health promotes a 'Total Self' culture where employees can authentically be themselves, emphasizing diversity, career development, and a supportive work environment.

What types of studies will the CRA I be involved with?

The CRA I will be involved with clinical trials, including real-world late phase studies, managing site support throughout the study lifecycle.

Will there be training provided for this role?

Yes, Syneos Health provides technical and therapeutic area training as part of the onboarding and ongoing development for employees.

Is the CRA I position a full-time role?

Yes, the CRA I position is a full-time role dedicated to sponsor projects.

Does Syneos Health have a commitment to compliance and accommodations?

Yes, Syneos Health is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations, when appropriate, to assist employees or applicants in performing essential job functions.

Syneos Health Commercial Solutions

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Syneos Health® (Nasdaq:SYNH) is the only 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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.