CRA (Level I)

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.

Discover Impactful Work:

Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

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.
• Assess investigational product through physical inventory and records review.
• Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that identified issues are being resolved and that the data is being recorded.
• May participate in investigator meetings as necessary. Initiates clinical trial sites to ensure compliance.
• Performs trial close out and retrieval of trial materials. Conducts on-site and remote file reviews.
• 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.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Job Complexity; works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
• Job Knowledge; learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
• Supervision Received; normally receives detailed instructions on all work.
• Business Relationships; contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.

Keys to Success:

Education

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Experience

• Previous Clinical trial monitoring experience preferred.

• 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

• Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Good IT literacy skills, e.g., MS Word, Excel, Outlook, Power Point
• Ability to maintain customer focus through the utilization of good listening skills and attention to detail
• Good organizational and time management skills
• Ability to remain flexible and adaptable in a wide range of scenarios
• Well-developed critical thinking skills and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Ability to work in a team or independently as required

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and well-being 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 balancing 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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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.