Clinical Research Associate (Level I) - FSP

Thermo Fisher Scientific

1mo ago

Job
Full-time
Junior Level
Research & Development
Healthcare
Hamburg

AI generated summary

You need a life sciences degree or RN certification, minimal clinical monitoring experience, knowledge of ICH GCPs, strong communication skills, and the ability to travel up to 80%.
You will monitor clinical sites, ensure compliance, document findings, maintain communication with teams, conduct inventory reviews, and assist in project initiatives and reporting as needed.

Requirements

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
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.
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.
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 is the work schedule for the Clinical Research Associate (Level I) position?

The work schedule is standard, operating from Monday to Friday.

Is travel required for this role?

Yes, this role requires independent travel up to 80%, which may include traveling by automobiles, airplanes, and trains.

What educational background is required for this position?

A Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification is required.

Is prior experience in clinical monitoring necessary for this role?

Minimal clinical monitoring experience is preferred, which can be comparable to 2 years in a clinical environment involving clinical trials, medical terminology, or health care.

What skills are essential for success in this role?

Essential skills include good oral and written communication, interpersonal skills, organizational skills, critical thinking abilities, and proficiency in Microsoft Office and other software.

What type of environment does this role typically operate in?

The work environment is primarily office-based, but it can include non-traditional work environments such as healthcare or laboratory settings, with potential exposure to hazardous elements.

Will I need to participate in investigator meetings?

Yes, you may need to participate in investigator meetings as necessary for the role.

Are there opportunities for career development within the company?

Yes, Thermo Fisher Scientific provides resources and support for individual career goals and development prospects.

What are the company's values regarding employees?

Thermo Fisher Scientific values the health and well-being of employees and encourages a healthy and balanced work environment.

Are there benefits associated with this position?

Yes, the position offers competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits.

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.