Remote Site Monitor Central

hace 3 semanas

Ciudad de México Thermo Fisher Scientific A tiempo completo

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
Description - ExternalPrepares and analyzes clinical trial patient datasets, such as laboratory data, vital signs data, tumor response data, imaging data, quality of life and well-being questionnaire data, or adverse events data, for clinical research purposes.

Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry by working closely with mentors, attending presentation / teaching events, and contributing to other general department documents and policies by assisting mentors with implementing best practice documents and articles.

RSM-Central performs related activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and CRG SOPs. In addition, reviews study data from various sources remotely. They develop collaborative relationships with different stakeholders as applicable.

Reviews ad-hoc clinical listings review, tracks and trends violations and deviations, site status, enrollment, CRF status and SAE follow up.

Provides trial status tracking and progress update reports to study manager.

Participates in the investigator payment process, if applicable.

Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship. Contributes to company, client, and federal/local regulatory requirements/audit responses.

**Qualifications - External**
- Bachelor's degree in life science-related field, IT, Engineer, Biostatistics or Programing.
- Prior clinical research experience 0-1 year as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities. In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management.

**Skills**:

- Firm understanding and use of Excel
- Good attention to detail
- Good problem solving skills
- Good written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
- Capable of effectively organizing and managing multiple assignments with challenging timelines
- Capable of adapting and adjusting to changing priorities
- Positive attitude and the ability to work well with others
- Demonstrated initiative and motivation
- Firm understanding of relational data base structure and complex data systems
- Capable of effectively capturing and reviewing data
- Capable of providing quality control support

**Education and Experience**:

- Bachelor's degree in life science-related field or an Associate's degree in Nursing with a current RN license. Internal applicants with current or previous CRA experience will be considered with or without the education requirements.- Prior clinical research experience, 3+ years as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities.- Prefer individuals who aspire to advance into a CRA role.- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._

**Knowledge, Skills and Abilities**:

- Excellent medical/therapeutic area knowledge and solid understanding of medical terminology- Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and PPD procedural documents- Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP)Ability to evaluate medical research data- Ability to advise, counsel, and motivate investigational sites- Effective oral and written communication skills with the ability to communicate effectively with medical personnel- Excellent interpersonal and customer service skills- Good organizational and time management skills- Proven flexibility and adaptability- Strong attention to detail- Ability to work in a team or independently, as required- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.- Ability to coach and mentor site personnel.- Good computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable- Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards- Excellent English language and grammar skills- Ability to mentor junior team members, as

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