Clinical Trial Project Assistant
The Clinical Trials Project Assistant will provide broad-base administrative, regulatory, and operational support to Clinical Project Management team for Clinical Operations. The Clinical Trials Project Assistant will work with all Clinical Project Managers. The role will support some of the administrative and regulatory requirements of clinical trials managed by CPMs. This is an entry level role with the opportunity for growth within the company.
- Assists with study start up activities including:
- Collating and tracking documents for sponsor and site level green light
- Creating and supply of study tools and supplies for the site
- Preparation and distribution of materials for logistical meetings and SIV
- TMF Management
- Maintains and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOPs/WIs requirements.
- Manage regulatory documents for active studies.
- Tracks study expiration/renewal dates of clinical documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.)
- Preparation, filing and archiving of clinical trial documentation and reports according to the scope of work and standard operating procedures
- Prepares, ships and manages inventory of study related supplies
- Assist with the tracking of patient samples
- Assists with the development of study specific tools
- Assists with maintaining up to date investigator, site and vendor information (addresses, phone numbers, fax numbers, personnel names and email addresses, etc.)
- Assists with coordinating and arranging meetings, and recording meeting minutes
- Triage and support clinical site staff with questions related to resupply requests or general study related questions.
- Provides logistical support for Project Managers and study team
- Provides administrative support to the Clinical Operations team
- Assist with preparations for other meetings (eg. CRO Face to Face meetings, Investigator Update meetings, etc.)
- Create and maintain database records.
- Work side-by-side with the Clinical Operations team and assist with specified tasks as needed.
- Attend educational events related to clinical research.
Qualifications and Requirements
To be considered for this position, applicants must meet the following requirements:
- Associate degree or an equivalent combination of education and experience that demonstrate the skills, knowledge and abilities required to perform the position.
- Knowledgeable of medical terminology and concepts.
- Bachelor’s degree in a relevant field of study.
- Knowledge of Good Clinical Practice
- Knowledge of clinical trial concepts and activities
- One or more years of relevant clinical research or healthcare or basic science experience.
Other Skills and Abilities
- Excellent interpersonal, written and verbal communication skills.
- Strong analytical skills.
- Well-organized and possess the ability to manage time appropriately. Systematically perform activities in a timely and accurate manner.
- Ability to assess and re-prioritize quickly to meet deadlines in a fast-pace environment.
- Flexible and open to change.
- Ability to work independently.
- Proficient in computer applications including Microsoft Office, Word, Excel.
- Ability to work independently.
Immatics US, Inc. is a highly innovative biopharmaceutical company headquartered in Houston, TX (USA) and co-launched, together with MD Anderson Cancer Center, as a subsidiary of Immatics Biotechnologies GmbH, headquartered in Germany. We are a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting immunotherapies for the treatment of cancer.
Our transformative product candidates are - best in class - Adoptive Cell Therapies and Bispecific TCR molecules. These products are directed against tumor targets that have been identified and validated by Immatics' proprietary and world-leading XPRESIDENT® technology.
Our mission is to bring the power of T-cell redirecting immunotherapies to cancer patients with more than 100 targets covering 20 major solid and liquid tumors with 80% of the discovered targets being novel. We have 2 proprietary technology platforms and 8 proprietary development programs, with 2 in the clinical trial phase as of 2017.
The US has a team of over 40 highly qualified research, medical and business professionals and we are looking for team members who constantly strive for excellence and whose motivation is driven by their dedication to innovation and science.