Sr CRA (Level II)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary:
As a Sr CRA (Level II), you will perform and coordinate all aspects of the clinical monitoring and site management process. You will be responsible for conducting remote or on-site visits to assess protocol and regulatory compliance and handling required documentation. You will act 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. You will also develop collaborative relationships with investigational sites and client company personnel.

Position requirements

• 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 product through physical inventory and records review.
• Conducts monitoring tasks in accordance with the approved monitoring plan and documents observations in reports and letters in a timely manner
• Raises 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 identified issues are being resolved and that the data is being recorded.
• 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. Initiates clinical trial sites to ensure compliance.
• Performs trial close out and retrieval of trial materials. Conducts on-site file reviews.
• Facilitates effective communication between investigative sites, the client company and the internal 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.
• May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members.

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

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor).
• 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 and Abilities:

• Effective clinical monitoring skills
• Proven understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to critical approach, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to handle Risk Based Monitoring concepts and processes
• Effective 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
• Effective interpersonal skills
• Strong attention to detail
• Effective organizational and time management skills
• 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: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

Working 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:

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• Frequent 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.
• Align with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.