CRA to Sr.CRA Home-based/Hybrid

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Thermo Fisher Scientific offers an opportunity to contribute to a positive global impact. Help our customers improve the world's health, cleanliness, and safety. Achieve your career goals with our support while advancing science through research, development, and delivery of life-changing therapies. Our work spans laboratory, digital, and decentralized clinical trial services in 100+ countries.

Our global Clinical Operations colleagues in PPD's clinical research services offer comprehensive support for clinical trials, from study initiation to monitoring and study completion. We work on both commercial and government contracts, assisting clients in designing and implementing clinical programs to ensure efficient and high-quality studies.

Job Summary:

Oversees and coordinates the clinical monitoring and site management process. Performs on-site or remote visits to assess compliance and manage documentation. Manages procedures and guidelines from different sponsors and monitoring environments. Ensures the trial is conducted according to protocol and regulations to protect subjects' rights and data reliability. Builds relationships with investigational sites. Task matrix outlines specific responsibilities.

Responsibilities:

• Applies a risk-based monitoring approach to investigator sites. Utilizes RCA, critical thinking, and problem-solving skills to identify and address site process failures. Implements corrective/preventive actions to ensure compliance and mitigate risks.
• Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
• Assesses investigational products through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Advances observed deficiencies and issues to clinical management promptly and follows all issues through to resolution.
• Regularly communicates with investigative sites in between monitoring visits to ensure protocol adherence, issue resolution, and timely data recording.
• 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.
• 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).
• Performs QC check of reports generated from the 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 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.
  
  

Qualifications:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
• Valid driver's license where applicable.
• In certain situations, having the right education, training, and/or relevant experience may be enough to meet the requirements of the position.
• We highly value candidates with a Bachelor’s degree or equivalent experience in a life sciences related field, or a Registered Nursing certification. Relevant formal academic/vocational qualification is also preferred.
  
  

Knowledge, Skills, Abilities:

• 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: a proactive attitude, detailed investigation for appropriate root cause analysis, and effective problem-solving.
• Ability to manage 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.