高级临床研究专员I

The Senior Clinical Research Associate I is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards.
The Senior Clinical Research Associate I role is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders.
The Senior Clinical Research Associate I is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner, and other members of the study team, as required, in activities associated with the set-up, running and close out of sites in a clinical trial.
Clinical Trial Monitoring:

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines and quality

• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site initiation through to database lock, ensuring relevant timelines and quality deliverables are met

• During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery

• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites

• Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks

• Attend investigator meetings when required (virtual or F2F).

• Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level

• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the Study Monitoring Plan, SOPs and commensurate with emerging issues and technologies.

• Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

• Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics

• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues

• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines

• Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities.

• Support database release as needed

• May undertake the responsibilities of an unblinded monitor where required.

Clinical/Scientific and Site Monitoring Risk:

• Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team

• Interact with investigator site heath care professionals in a manner which enhances Pfizer’s credibility, scientific leadership and in order to facilitate Pfizer’s clinical development goals

• Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators

• Drive Quality Event remediation, when applicable

• Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable

Other:

• Mentor/train Clinical Research Associates as assigned

• Serve as anSME for CRA-related processes

• Participate in regional or local working groups/process improvement initiatives

• Perform activities under guidance of a Site Care Partner prior to site activation e.g. feasibility and site selection, PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable),including management of issues that may compromise time to site activation

• Conduct co-monitoring activities as requested

Work Location Assignment: Remote
Pay Transparency Note:
Minimum annual gross base salary: 129 750 PLN
Annual bonus: 15%
Corporate benefits as per Pfizer Pay Policy, including Medicover, Multisport, life insurance, private pension plan and other.

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address .
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
MedicalOriginally posted on Himalayas