FSP Clinical Research Associate II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

CRA (Level II)

Purpose:

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. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions and Other Job Information:

Major Job

Responsibilities

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. 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 (CTMS)).

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.

Travel requirement >75%.

Job Knowledge

Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Job Complexity

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Supervision

Received /

Freedom to act

Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgement within defined procedures and practices to determine appropriate action.

Interactions /

Business

Relationships

Contracts are primarily internal to the company with infrequent external customer/vendor contact on routine matters. Builds productive internal/external working relationships.

Qualifications:

Education and Experience:

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 1 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 :

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

Management Role:

No management responsibility.

Working Conditions and Environment:

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

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

Physical Requirements:

Ability to work in an upright and /or stationary position for 6-8 hours per day

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists

Frequent mobility required.

Occasional crouching, stooping, with frequent bending and twisting of upper body and neck

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

Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences

Frequently interacts with others to obtain or relate information to divers