Neogene Therapeutics is a pre-clinical stage biotechnology company aiming to change the treatment paradigm for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.
Oversees the progress of clinical studies at investigative sites and ensures that studies are conducted, recorded, and reported in accordance with the clinical study protocol, Neogene standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Responsibilities include, but are not limited to:
Conducting site management in accordance with the monitoring plan and Sponsor SOP(s) to ensure adherence to the study protocol, investigator’s brochure, study procedure manuals, ICH-GCP, and other local regulations governing clinical trials.
Conducting monitoring visits (eg, study initiation, interim, close-out visits) and monitoring oversight in accordance with the monitoring plan and Sponsor SOP(s).
Verifying data entered into the electronic CRFs is consistent with source records (source data verification). May require remote source data verification as necessary.
Escalating issues in accordance with the monitoring plan, generating action plan(s) (as needed), and following up on issue status and action plan through completion, while maintaining adequate documentation.
Reviewing the study protocol, study manuals, and other related documents as specified by the Sponsor; and attending or completing trainings to ensure own knowledge and understanding is up to date.
Training site investigators and personnel on study protocol and other relevant protocol procedure manuals.
Collecting required essential documents and other documents and correspondences to be archived in the trial master file (TMF) throughout the study.
May attend meetings with the Sponsor or external vendors contracted by the Sponsor to discuss site status.
Ensuring site has an adequate amount of clinical study supply and equipment is adequately maintained.
No supervisory responsibilities.
Excellent verbal and written communication skills.
Excellent organizational skills and attention to detail.
Strong analytical and problem-solving skills.
Strong knowledge of clinical trials.
Strong knowledge of the principles of ICH-GCP as applicable to conduct of clinical research.
Knowledge of European regulation governing clinical trials.
Knowledge of and familiarity with medical terminology, specifically as related to oncology.
Ability to function well in a high-paced environment and able to handle several priorities within a complex trial.
Proficient with Microsoft Office Suite or related software.
Education and Experience
Degree in related field, preferably in clinical, science, or health-related field
Minimum 2 years as CRA with experience monitoring study sites.
Prior experience with monitoring clinical studies in the solid tumor indication.
Prior experience with monitoring cell therapy clinical studies is strongly preferred.
While performing the duties of this job, the employee is regularly required to:
Sit and talk or hear.
The employee frequently is required to use hands to finger, handle, or feel.
The employee is occasionally required to stand, walk, and reach with hands and arms.
The employee must occasionally lift and/or move up to 10 pounds.
Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
May be required to travel by plane or car 70-85% of the time
Must have valid driver’s license, passport, as required.
May require vaccinations to access the clinical site.
We offer the opportunity to join a highly dynamic biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.