Assistant CRA - Ciudad de México - PPD Latin America

Descripción

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Mexico City

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies. As an Assistant CRA (ACRA), you combine knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market.

You take ownership, anticipate problems, find solutions, and deliver results. At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose: Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.

Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned

• Completes and documents study-specific training
• Orients and trains on any company/study-specific systems
• Provides in-house support during pre-study assessments and with pre-study asssessment waivers, as agreed for project
• Supports to customize Site ICF with site contact details, as needed
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments
• Verifies document collection and RCR submission status; updates site EDL and verifies site information
• Reviews patient facing materials and review translations, as directed
• Supports site staff with the vendor related qualification process, where applicable
• Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study
• Provides support to follow-up on site staff training, as applicable
• Coordinates and supports logistics for IM attendance, as directed
• Support with maintenance of vendor trackers, as directed
• Coordinates study/site supply management during pre-activation and subsequent course of the study
• Supports Essential Document collection, review and updating in systems, as applicable
• Follow up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed
• Supports ongoing remote review of centralized monitoring tools, as directed
• Supports Site payments processes by coordinating with various functional departments within organization and site.

Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period

• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable
• Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed
• May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix
• May perform a specific role profile for FSP opportunities according to Client requests
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner

Bachelor's Degree in a life science-related field or relevant/equivalent formal academic/vocational qualification Clinical research experience would be an advantage.

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.

• Basic medical/therapeutic area knowledge and understanding of medical terminology
  • Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
  • Effective oral and written communication skills
  • Excellent interpersonal and customer service skills
  • Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
  • 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.
• Proficient 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

PPD clinical research services values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/ requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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