Clinical Research Associate II/Sr.

Join Immatics and shape the future of cancer immunotherapy; one patient at a time!

Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment.

Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology.

Why Join Us?

• Innovative Environment: Help to pioneer advancements in cancer immunotherapy.

• Collaborative Culture: Be part of a diverse team dedicated to your professional growth.

• Global Impact: Contribute to therapies that make a lasting impact on patients globally.

We are seeking an Clinical Research Associate II/Sr. tosupport our Clinical Operations team.The CRA II/Sr. will be responsible for ensuring clinical trial site management and monitoring activities in compliance with GCP guidelines, national and local regulations or laws, and SOPs.

FLSA Classification : Hourly, Non-Exempt
Schedule : 8:00 AM - 5:00 PM; Monday to Friday
Reports to : Associate Director - Clinical Operations
Location : Remote

What You'll Do:

As an CRA II/Sr . you will play a key role in:

• Support clinical trial site feasibility and site selection process

• Conduct all aspects of clinical monitoring for clinical trials including conduct of site qualification visits, site initiation visits, routine monitoring visits and close-out visits at clinical trial sites

• Support the maintenance of the Investigator Site Files and sponsor Trial Master Files

• Conduct all aspects of site management as prescribed in the clinical trial specific functional plans

• Prepare accurate and timely trip visit reports

• Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiates appropriate actions to achieve objectives

• Organize and make presentations at Investigator Meetings

• Participate in the development of Case Report Forms and clinical trial documents

• Act as primary contact for clinical trial supplies and other suppliers (vendors)

• Participate in regular clinical trial team meetings

Secondary Functions:

• Mentor less experienced or new CRA colleagues

• Perform CTM tasks as appropriate and as delegated by the CTM

• Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates

Required Experience and Education:

• Min. Bachelor's Degree, preferably in life science or nursing, or equivalent

• At least 4 years of on-site monitoring experience in the pharmaceutical/ biotechnology industry (incl. all monitoring visit types)

• In-depth knowledge of ICH-GCP, FDA and EMA and applicable local regulations and laws

• Understanding of basic medical oncology terminology and science preferable

• Exceptional attention to detail

• Advanced presentation and organizational skills

• Comprehensive understanding of priorities within own scope with limited interaction with the supervisor

• Proactively driving quality and efficiency to meet timelines and milestones in own scope

• Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS)

Preferred Experience and Education:

• Proactively driving company standards, global harmonization and innovation in own scope

• Full reflection on complex process structures and connections

• Fostering innovation and development in own area of expertise

Comp etencies

• Intermediate leadership skills and strong team player

• Positive attitude and willingness to learn and contribute to a team

• Proficient time management to work efficiently and economically

• Strong ability to identify, deeply analyze and communicate problems

• Advanced ability to develop and implement solutions within own area of responsibility

• Analytical reasoning and good project management skills

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.

Travel required:

• Willingness to travel up to 75%

• Valid Driver's License preferable

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).

• Pushing - Exerting force upon an object so that the object moves away from the object.

• Pulling - Exerting force upon an object so that the object moves toward the force.

• Sitting - remaining in a sitting position for at least 50% of the time.

• Standing/Walking - remain on one's feet in an upright position at a workstation.

• Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

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.

What do we offer?

At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics

Comprehensive Benefits :

• Competitive rates for Health, Dental, and Vision Insurance

• 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.

• Sick Time Off - 56 hours

• 12 Paid Holidays

• 100% Employer-Paid Life Insurance up to at 1x annual salary, up to 100K ( club together)

• 100% Employer Paid Short- and Long-Term Disability Coverage

• 401(k) with Immediate Eligibility & company match...

• • You are eligible for 401(k) plan participation as of your first paycheck.
  • The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.

• Partially paid Parental Leave for eligible employees. (3 weeks)

• Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.

Professional Growth :

• Opportunities to work with leading experts in the field of T-cell immunotherapy.

• Company provided learning and development opportunities

• Fast paced, high demand collaborative and dynamic environment.