FSP Sr Clinical Research Associate

Environmental Conditions

Office

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

Documents observations in reports and letters in a timely manner using approved business writing standards.

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.

Ensures a shared responsibility with other project team members on issues/findings resolution.

Clinical Trial Management System, CTMS).

Performs QC check of reports generated from CTMS system where required.

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 essential documents are complete and in place, according to ICH-GCP and applicable regulations.

Conducts on-site file reviews as per project specifications.

Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.

Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).

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 other project work and initiatives for process improvement, as required.

Travel requirement

resolves a wide range of issues in creative ways.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Supervision Received /Freedom to act

Represents the department as a prime contact on projects. Networks with senior internal and external personnel in own area of expertise.

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

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).

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.

Effective clinical monitoring skills

Demonstrated 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 mindset, in-depth investigation for appropriate root cause analysis and problem solving

Ability to manages 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

Ability to remain flexible and adaptable in a wide range of scenarios

Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software

Good English language and grammar skills

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

Personal protective equipment required such as protective eyewear, garments and gloves

Must be able to comply 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

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 developed both in-house and offthe-shelf