Clinical Research Associate (Level II)

Thermo Fisher Scientific; United States; Remote; USD 65,000 - 85,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Clinical Research Monitor to ensure compliance through careful monitoring of investigative sites. The role involves remote and on-site visits, documentation management, and communication across teams to maintain adherence to protocols and regulations. Ideal candidates will possess strong analytical skills and a background in life sciences.

Qualifications

• Bachelor's degree in a life sciences related field or Registered Nursing certification.
• Previous experience as a clinical research monitor or completion of PPD Drug Development Fellowship.
• Good English language and grammar skills.

Responsibilities

• Conducts remote or on-site visits for protocol and regulatory compliance.
• Documents observations and escalates issues to clinical management.
• Monitors sites using a risk-based approach.

Skills

Clinical monitoring skills

Critical thinking

Oral communication

Written communication

Time management

Interpersonal skills

Risk Based Monitoring

Attention to detail

Education

Bachelor's degree in life sciences or Registered Nursing certification

Tools

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized 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.

EssentialFunctions:

• Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance 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 usingapproved business writing standards. Escalates observed deficiencies and issuesto clinical management expeditiously and follow all issues through to resolution.

• May need to maintain regular contact between monitoring visits withinvestigative sites to confirm that the protocol is being followed, that previouslyidentified issues are being resolved and that the data is being recorded in atimely manner. Conducts monitoring tasks in accordance with the approvedmonitoring plan. Participates in the investigator payment process. Ensures a

• shared responsibility with other project team members on issues/findingsresolution. Investigates and follows-up on findings as applicable.

• Participates in investigator meetings as necessary. Identifies potentialinvestigators in collaboration with the client company to ensure the acceptabilityof qualified investigative sites. Initiates clinical trial sites according to therelevant procedures to ensure compliance with the protocol and regulatory andICH GCP obligations, making recommendations where warranted. Performs trialclose out and retrieval of trial materials.

• Ensures that required essential documents are complete and in place, accordingto ICH-GCP and applicable regulations. Conducts on-site file reviews as perproject specifications.

• Provides trial status tracking and progress update reports to the Clinical TeamManager (CTM) as required. Ensures study systems are updated per agreedstudy conventions (e.g. Clinical Trial Management System).

• Facilitates effective communication between investigative sites, the clientcompany and the PPD project team through written, oral and/or electroniccontacts

• Responds to company, client and applicable regulatoryrequirements/audits/inspections.

• Maintains & completes administrative tasks such as expense reports andtimesheets in a timely manner.

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

• Contributes to other project work and initiatives for process improvement, asrequired.

Education and Experience:
Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent andrelevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1years as a clinical research monitor) or completion of PPD Drug Development Fellowship.

In some cases an equivalency, consisting of a combination of appropriate education, trainingand/or directly related experience, will be considered sufficient for an individual to meet therequirements of the role.

Good English language and grammar skills.

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 regulationsand 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 medicalpersonnel

• Ability to maintain customer focus through the utilization of good listening skills, attention to detailand the ability to perceive customers’ underlying issues

• Good organizational and time management skills

• Effective interpersonal skills

• Attention to detail

• Ability to remain flexibile and adaptable in a wide range of scenarios

• Ability to work in a team or independently as required

• Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriatesoftware

• Good presentation skills