Location: Cambridge, MA
The Clinical Research Department is responsible for the overall contribution of clinical information and support to the product development programs at H3 Biomedicines. The Department is responsible for clinical development strategy, study design, data analysis, and reporting. The Department also oversees the scientific content of clinical information distributed outside of the company.
The Clinical Research Scientist (CRS) will work closely with a study Clinician in the Clinical Research group to support the product development programs. The CRS will help drive effective clinical development and quality execution of the clinical development plan and clinical studies. An important part of the role will be accountability for the day-to-day clinical deliverables for the program, with a focus on clinical studies that are ongoing and being developed. The CRS, working closely with the study Clinician, will perform functions that require some degree of clinical judgment; however, the responsible Clinician will retain ultimate accountability for the clinical decisions.
Principal Duties and Responsibilities
- Support and collaborate with multiple functional areas, including Clinical Operations, Biostatistics/Data Management, Pharmacovigilance, and Regulatory Affairs, to ensure the effective startup, conduct, and close-out of clinical studies.
- Assist in the development of clinical sections of various documents including protocols, clinical study reports, Investigator’s Brochures, and clinical development plans.
- Participate in the review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, Case Report Forms, Data Management Plans, Clinical Study Reports, etc.
- Assist in answering questions from CROs, investigators and other site personnel regarding clinical and study conduct questions to help ensure patient safety and maintain appropriate adherence to the protocol.
- Participate in the review of SAE reports, SAE listings, medical coding, tables and listings of safety and efficacy data, and other output from clinical studies.
- Assist with managing logistics in support of clinically related project deliverables (e.g. face-to-face meetings, virtual meetings, training sessions, etc.).
- Support clinical team in conducting pertinent literature reviews in support of project deliverables.
- In conjunction with the study Clinician, create and review presentations for internal and external meetings.
- Contribute to the preparation of abstracts, posters, presentations, and manuscripts.
- Assist with the cleaning of clinical data through review of patient profiles, tables, listings etc.
QualificationsClinically relevant degree in Life Sciences/Nursing/healthcare with a minimum 5 years Clinical Research experience Early Phase Oncology Studies. Knowledge of ICH and GCP. Strong interpersonal, communication, and presentation skills. Ability to serve as a proactive team member and to work independently with minimal supervision. Strong analytical and problem solving skills with exceptional organization and attention to detail. Proficient using normal office software; Microsoft Word, Excel and PowerPoint.
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.Submit Your Résumé