Sr Clinical Research Associate (CRA)/Principal CRA - Spanish Fluent - FL, GA, KY, NC, OH, TN
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

This opening is targeting experienced onsite traveling CRAs with two or more years of CRA experience who are fluent in Spanish and have experience monitoring cell or gene therapy, oncology/hematology, rare neurological diseases, ophthalmology, psychiatry and neurodegenerative disorders (including Alzheimer's Disease) or kidney and metabolic indications.

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.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:

As an experienced CRA, you will perform and coordinate all aspects of the clinical monitoring and site management process. You will be responsible for conducting remote and on-site visits to assess protocol and regulatory compliance and managing required documentation. We are currently hiring for Sr CRA (Level I), Sr CRA (Level II), and Principal CRA openings.

A day in the Life:

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  
• Assess investigational products through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards.
  
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
  
• Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
  
• Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
  
• Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  
• Performs trial close out and retrieval of trial materials.
  
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
  
• Conducts on-site file reviews as per project specifications.
  
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
  
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
  
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
  
• Responds to company, client and applicable regulatory requirements/audits/inspections.
  
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
  
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
  
• Contributes to other project work and initiatives for process improvement, as required.
  
• Progressive and/or more extensive job duties and responsibilities may be expected with increasing CRA level
  

Keys to Success:

Education:

• All levels: Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
  

Experience:

• Sr CRA (Level I): Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor)
  
• Sr CRA (Level II): Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor)
  
• Principal CRA: Considerable clinical research monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) with a demonstrated high level of expertise in all aspects of clinical monitoring
  
• All levels: Valid driver's license where applicable.
  

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, Abilities:

• Proven clinical monitoring skills
  
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
  
• 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 manage Risk Based Monitoring concepts and processes•Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
  
• Good organizational and time management skills
  
• Effective interpersonal skills
  
• Attention to detail
  
• Ability to remain flexible and adaptable in a wide range of scenarios
  
• Ability to work in a team or independently as required
  
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
  
• Good English language and grammar skills
  
• Good presentation skills
  
• Progressive and/or more extensive knowledge, skills, and abilities expected with increasing CRA level
  

Work Environment:

Thermo Fisher Scientific 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.
  
• Able to work in non-traditional work environments.
  
• Able 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 have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
  
• This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
  

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