11 дней назад
Senior Clinical Research Associate I (Clinical Research)
129 750PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate I (Clinical Research): Managing investigator sites and monitoring clinical trials from site initiation through close-out with an accent on patient safety, Good Clinical Practice, protocol compliance, and site quality. Focus on resolving protocol and data issues, supporting recruitment and database release, overseeing investigational products, and coordinating corrective actions with investigators and study teams.
Location: Poland - Remote
Minimum annual gross base salary: 129,750 PLN; annual bonus: 15%
Company
is a pharmaceutical and healthcare company focused on developing medicines and improving patient outcomes through clinical research and digital transformation.
What you will do
- Manage investigator site activities from site initiation through database lock and study close-out.
- Conduct onsite and remote monitoring in line with monitoring plans, applicable laws, Good Clinical Practice, standard operating procedures, and standards.
- Act as the primary contact for assigned investigator sites, supporting enrollment, site activation, recruitment, training, and protocol compliance.
- Monitor adverse events and serious adverse events, resolve data queries and site issues, and coordinate corrective and preventive actions.
- Maintain required trial documentation, reports, tracking, site follow-up letters, protocol deviations, recruitment data, and clinical supply records.
- Oversee investigational product receipt, handling, storage, accounting, and destruction, and support database release when required.
Requirements
- Experience managing and monitoring investigator sites in clinical trials.
- Thorough knowledge of the assigned product, protocol, therapy area, clinical trial risks, and patient safety requirements.
- Ability to work with investigators, healthcare professionals, vendors, study teams, and site personnel.
- Ability to resolve protocol-related issues, data queries, audit observations, and quality events within required timelines.
- Availability to attend investigator meetings virtually or face to face and conduct site monitoring activities as needed.
- Ability to mentor and train Clinical Research Associates and serve as a subject matter expert for CRA-related processes.
Culture & Benefits
- Flexible remote workplace designed to support work-life harmony.
- Medicover and Multisport benefits.
- Life insurance and private pension plan.
- Annual bonus opportunity of 15%.
- Patient-centric culture guided by courage, joy, equity, and excellence.
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