Associate Clinical Research Manager (ACRM) at Thermo Fisher Scientific

Austin, Texas, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years); equivalency of appropriate education, training, and/or directly related experience may be considered
Basic understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information, and problem solving
Demonstrated ability to exercise discretion and sound judgement
Adequate decision-making, negotiation, and influencing skills
Decent communication skills and English fluency
Decent organizational skills
Essential proficiency in basic computer applications
Decent interpersonal skills to work in a team environment

Responsibilities

Conducts at least one ongoing clinical trial and manages various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings
Acts as liaison between senior project team members and study subjects
Interacts with the research site team and interdepartmental staff to ensure positive interactions with participants at site for study planning, from initiation to closeout
Actively participates with senior project team members to meet project needs, projections, and deadlines
Oversees organization and accuracy of project documents
Works with management on understanding departmental needs and improving processes
Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines
Records all patient information and results from tests as per protocol on required forms
Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study
Promotes the company and builds a positive relationship with patients to ensure retention
Attends site initiation meetings and all other relevant meetings to receive training on protocol
Calls patients and makes follow-up calls as needed to provide information or results
Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and completed within timeframe
Gathers source documents and updates as needed, always ensuring relevant and most up-to-date information is recorded
Adheres to company COP/SCOP
May dispose of waste according to standards and assist in keeping a general neat appearance of the facility

Skills

Clinical Trials

GCP

ICH

FDA Regulations

IRB

Study Management

Patient Data Recording

Protocol Compliance

Site Liaison

Project Documentation

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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