Sr CRA I Seville. Sponsor dedicated.

Syneos Health Commercial Solutions

18d ago

Job
Full-time
Mid & Senior Level
Science
Healthcare
Madrid
Remote

AI generated summary

You need a Bachelor's or RN in a related field, GCP knowledge, strong computer skills, effective communication, basic critical thinking, and the ability to travel up to 75% regularly.
You will monitor sites, verify data integrity, ensure compliance, manage communication, train junior staff, and support site activities throughout the study lifecycle.

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. Basic level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis

Responsibilities

Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (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 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.
Per 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 via review of site source documents and medical records
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 study 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.
Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. 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, and may, with supervision, lead, 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.
May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
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
Knowledge of local requirements for real world late phase study designs
Chart abstraction activities and data collection
As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
Identify and communicate out of scope activities to Lead CRA/Project Manager
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
Identify operational efficiencies and process improvements
Develop country level informed consent forms
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
Participate in bid defense meetings

FAQs

What is the role of a Senior Clinical Research Associate I at Syneos Health?

The Senior Clinical Research Associate I is responsible for site qualification, initiation, monitoring, management, and close-out visits, ensuring compliance with regulatory guidelines, protocols, and good clinical practices.

What qualifications are required for this position?

A Bachelor's degree or RN in a related field or equivalent education, training, and experience is required, along with knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.

Is travel required for this position?

Yes, the position may require up to 75% travel on a regular basis.

What does the training and development look like at Syneos Health?

Syneos Health is passionate about developing its people through career progression, supportive management, technical training, and a total rewards program.

Are there opportunities for mentorship in this role?

Yes, the Senior CRA I may provide training or mentorship to junior level CRAs and may perform training and sign-off visits for them as assigned.

What additional responsibilities does a Senior CRA I have for Real World Late Phase studies?

Additional responsibilities include site support throughout the study lifecycle, knowledge of local requirements for study designs, chart abstraction activities, and building relationships with sponsors and local staff.

How does Syneos Health support diversity and inclusion?

Syneos Health is dedicated to fostering a Total Self culture that embraces diversity of thought, backgrounds, cultures, and perspectives, creating a workplace where everyone feels they belong.

Can you describe the company culture at Syneos Health?

The company culture is characterized by passionate problem-solving, collaboration, and a commitment to making work simpler and more efficient for both employees and customers.

What is the focus of Syneos Health?

Syneos Health focuses on placing the customer and the patient at the center of its operations, aiming to accelerate the delivery of therapies that can change lives.

Will I be involved in the preparation for audits in this role?

Yes, the Senior CRA I provides guidance towards audit readiness standards and assists in the preparation for audits and necessary follow-up actions.

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.