Lead CRA

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.

Location/Division Specific Information

Performs and coordinates different aspects of the clinical monitoring and site management process.

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. 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. Develops collaborative relationships with investigational sites and client company personnel. Assists project manager or clinical team manager on assigned projects and will take a lead role where required. Supports the line manager to mentor, train and contribute to the development of junior clinical team members.

A day in the Life:

• Monitors investigator sites with ability to manage complex studies and/or challenging sites using 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 product through physical inventory and records review. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Provides updates on potential trends noted across multiple sites and discusses strategies for their management to the Clinical Team Manager (CTM).
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
• 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. Ensures trial close out and retrieval of trial materials.
• Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

Keys to Success:

Education

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

Experience

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.

Valid driver's license where applicable.

Knowledge, Skills, Abilities

• Expert clinical monitoring skills
• Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
• Excellent critical thinking skills, including but not limited to: critical approach, in-depth investigation for appropriate root cause analysis and problem solving
• Proficient in Risk Based Monitoring concepts and processes
• Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
• Excellent oral and written communication skills
• Ability to maintain customer focus
• Excellent interpersonal skills
• Excellent organizational and time management skills
• Strong attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Effective presentation skills
• Ability to utilize problem-solving techniques applicable to constantly evolving environment
• Good digital literacy: proficient knowledge of Microsoft Office

Physical Requirements / Work Environment

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• Frequently drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Frequent mobility required.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software.
• Ability to communicate complex information and ideas so others will understand
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance

Benefits

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!