Clinical Research Associate - FSP - Sweden

ThermoFisher Scientific; Sweden; Remote; SEK 520,000 - 750,000; Full time

Job summary

PPD, part of Thermo Fisher Scientific, is seeking a Clinical Research Associate to monitor sites and ensure data integrity across studies. You will apply risk-based monitoring, SDR/SDV review, regulatory compliance, and communicate findings to the clinical team.

Education, English fluency and a science degree are required; you should be comfortable with ICH-GCP, EU/FDA regulations, and have a valid driver’s license.

Qualifications

• University degree in science field.
• Understanding of ICH-GCP, EU and FDA requirements.
• Fluency in English.
• Valid driver's license.

Responsibilities

• Monitors investigator sites using risk-based approach and identifies corrective actions.
• Ensures data accuracy through SDR, SDV and CRF review during monitoring activities.
• Assesses investigational product via inventory and records review.
• Documents observations in reports per timelines and standards.
• Escalates issues to clinical management and follows through to resolution.
• Participates in investigator payments and in team issue resolution.
• Participates in investigator meetings to identify qualified sites.
• Initiates sites per protocol, ensuring compliance with regulatory requirements.

Skills

Monitoring skills

ICH-GCP knowledge

English fluency

Problem solving

Risk-based monitoring

Communication

Team collaboration

Attention to detail

Education

University degree in science

Tools

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

This is a great opportunity for CRA's currently working within the life science sector for pharmaceutical companies, biotech companies or CRO's to work with a world-leading CRO.

Essential Functions

• 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 according to timelines using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follows 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.
• 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).
• 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.

Education and Experience

• University degree in a science related field
• Understanding of ICH-GCP, EU and FDA requirements
• Fluency in English
• Valid driver's license

Knowledge, Skills and Abilities

• Proven clinical monitoring skills
• Experience from working on Cell & Gene Therapy studies
• 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 require
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• CRA with experience from all study phases from start to close-out

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture (https://www.ppdi.com/careers/life-at-ppd) , where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our 4i Values

Integrity – Innovation – Intensity – Involvement

Clinical Research | Thermo Fisher Scientific

Our team of colleagues in clinical research services are at the forefront of getting cures to market.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.