.. to help them recover. Build rewarding relationships with patients during stays that start at two weeks. Open access to opportunity to learn, grow, advance, and build skills that last a lifetime. Certifications and Licensures: Current RN licensures appropriate to state regulations required. CPR certification .. read more
FLSA Classification : Non-Exempt/ Hourly
Schedule: Monday - Friday; 8:00 am - 5:00 pm
Department: Clinical Operations
Reports to: Head of Clinical Operations
Supervisory responsibilities: No
Location: Remote, with occasional travel to 13203 Murphy Road, Suite 100 Stafford, TX 77477
Position Summary/objective:
This position will provide administrative support to the Clinical Operation team.
Essential functions:
Work environment:
This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.
Physical demands:
Travel required:
Willingness to travel if necessary for business reasons.
Required education and experience:
Work authorization/security clearance requirements:
Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.
Affirmative Action/EEO statement:
Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law."
Other duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.
Schedule: Monday - Friday; 8:00 am - 5:00 pm
Department: Clinical Operations
Reports to: Head of Clinical Operations
Supervisory responsibilities: No
Location: Remote, with occasional travel to 13203 Murphy Road, Suite 100 Stafford, TX 77477
Position Summary/objective:
This position will provide administrative support to the Clinical Operation team.
Essential functions:
- Main responsibilities of this position will include but are not limited to the following tasks:
- Set-up, maintenance, close out and archival of in-house and outsourced electronic / paper Trial Master File (e/pTMF)
- Oversight of outsourced TMF set-up and maintenance
- Preparation of a TMF Management Plan
- TMF Filing Performance Review
- Archiving TMF
- Support to the GCP compliant TMF for clinical trials, incl. but not limited to:
- Set-up and maintenance of tracking tools
- Report preparation
- Prepares, reviews and/ or performs QC of clinical trial documents
- Develops and maintains SOPs, guidance documents & training material
- Basic organizational skills to structure own tasks and predefined working packages
- Identification of basic need and room for improvement within own scope
Work environment:
This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.
Physical demands:
- Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
- Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
- Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
- Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.
- Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
- Sitting - remaining in a sitting position for at least 50% of the time.
Travel required:
Willingness to travel if necessary for business reasons.
Required education and experience:
- Completed Apprenticeship in a life science/medical field or equivalent experience
- 4 years working experience in the clinical research area in the pharmaceutical/biotech industry with ICH-GCP knowledge
- Intermediate organizational skills to structure own tasks and predefined working packages
- Proactive contribution to development of team structure and processes
- Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF).
- Clear and efficient verbal and written communication in English
- Team-oriented and a strong team player
- Ability to identify, deeply analyze and communicate problems and advanced ability to develop and proactively propose suitable solutions
- Minimal supervision required for routine tasks
- Independent, accurate and attention to detail working style
- Ability of need and room for improvement within own scope
- Good understanding of priorities within own scope, prioritization requires limited interaction with supervisor
- High degree of initiative and intrinsic motivation to exceed basic expectations for own tasks and responsibilities
- Excellent verbal/written skills
- Works independently
- Strong communicator and collaborator
- Strong attention to detail
Work authorization/security clearance requirements:
Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.
Affirmative Action/EEO statement:
Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law."
Other duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.