Clinical Research Associate (Level I) - FSP

Thermo Fisher Scientific

1mo ago

Job
Full-time
Junior Level
Research & Development
Healthcare
Berlin

AI generated summary

You need a Bachelor's in life sciences or RN certification, minimal monitoring experience, strong communication and organizational skills, and ability to travel 80%.
You will monitor clinical sites, ensure compliance, manage documentation, assess investigational products, communicate with teams, and support trial progress through various administrative tasks.

Requirements

Education
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Experience
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Valid driver's license where applicable.
Knowledge, Skills, Abilities
Basic medical/therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Good interpersonal skills
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
Ability to remain flexible and adaptable in a wide range of scenarios
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
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
Work Environment
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

Responsibilities

Performs and coordinates different 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. 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.
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. May help to identify 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 team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains and 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.

FAQs

What are the work hours for the Clinical Research Associate (Level I) position?

The work schedule is standard Monday through Friday.

What type of environment will I be working in?

You will be working in an office environment.

What qualifications do I need to apply for this position?

You need a Bachelor's degree in a life sciences related field or a Registered Nursing certification, along with minimal clinical monitoring experience.

Is experience in clinical trials required for this role?

Minimal clinical monitoring experience is preferred, comparable to 2 years in a clinical environment.

Will I need to travel for this job?

Yes, this role requires independent travel up to 80%, including travel by automobiles, airplanes, and trains.

What skills are important for success in this role?

Important skills include good communication, organizational and time management abilities, critical thinking skills, and proficiency in Microsoft Office.

Are there opportunities for career development within Thermo Fisher Scientific?

Yes, Thermo Fisher Scientific provides resources to achieve individual career goals and offers outstanding career and development prospects.

What kind of benefits does Thermo Fisher Scientific offer?

Benefits include competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits.

Will I receive training for this position?

Yes, appropriate training will be provided, and individuals will be expected to attain working knowledge of ICH GCPs and applicable regulations.

Is teamwork emphasized in this role?

Yes, the ability to work in a team or independently is required, and collaborative relationships with investigational sites are crucial.

Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.