Senior Clinical Research Associate

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

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME
, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

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 a Senior
Clinical Research Associate to support our Clinical Operations. The Clinical Research Associate 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
:
Salary, Exempt

Schedule: Monday - Friday; 8:00 am - 5:00 pm; preferred Western region of USA

Department: Clinical Operations

Reports to: Associate Director, Clinical Operations

Supervisory responsibilities: No

Location: Fully Remote

Salary range: $ - $

What You'll Do:

As a Senior Clinical Research Associate, you will play a key role in supporting our Clinical operations:

• 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

Competencies

• 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

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…