In-house Clinical Research Associate (iCRA) Clinical Operations
Job Title: In-house Clinical Research Associate (iCRA)
Epizyme, Inc. is a fully integrated, commercial-stage
biopharmaceutical company committed to its mission of rewriting
treatment for cancer and other serious diseases through novel
epigenetic medicines. In addition to an active research and
discovery pipeline, Epizyme has one U.S. FDA approved product,
TAZVERIK® (tazemetostat), for the treatment of adults and pediatric
patients aged 16 years and older with metastatic or locally
advanced epithelioid sarcoma (ES) who are not eligible for complete
resection; adult patients with relapsed or refractory follicular
lymphoma whose tumors are positive for an EZH2 mutation as detected
by an FDA-approved test and who have received at least 2 prior
systemic therapies; and adult patients with relapsed or refractory
follicular lymphoma who have no satisfactory alternative treatment
options. These indications are approved under accelerated approval
based on overall response rate and duration of response. Continued
approval for these indications may be contingent upon verification
and description of clinical benefit in a confirmatory trial(s). The
company is also exploring the treatment potential of tazemetostat
in investigational clinical trials in other solid tumors and
hematological malignancies, as a monotherapy and combination
therapy in both relapsed and front-line disease settings. By
focusing on the genetic drivers of disease, Epizyme seeks to match
medicines with the patients who need them. For more information,
Epizyme has assembled a world-class team with a passion for
scientific innovation and a commitment to developing novel
epigenetic therapies. Join a dynamic, diverse and fun work
environment consistent with Epizyme’s cultural attributes for
success: camaraderie, collaboration, disciplined, innovative,
openness, patient-focused and resilient.
Support CPMs and field CRAs in all activities during pre-study
start-up, site initiation, remote monitoring, site management, and
database lock and study close-out;
Co-monitoring as needed to assist in review the ISF, perform
drug accountability and other tasks as deemed necessary;
Participate in the vendor selection process and oversee ongoing
vendor activities as appropriate;
Track screening and enrollment activities for ongoing studies
and provide updates in project team meetings
Prepare and distribute meeting agenda/minutes;
Assist in the development of study-related documents (ICFs,
protocols, IBs, study plans, study manuals, etc.);
Maintain TMF oversight and ensure all study documents are
accounted for in conjunction with CRAs and CTAs;
Create, maintain and distribute site/enrollment and monitoring
Review monitoring reports and help track issues and data trends
Perform regular reviews of data according to data
review/monitoring guidelines; work directly with the data
management and safety teams on query escalation;
Assist with contract process and budget tracking;
Function as business/system administrator for CTMS and eTMF
Education & Requirements:
Bachelor’s or associates degree in health sciences or related
Minimum of 2-3 years’ experience in clinical research with at
least 1-2 years’ experience as a Clinical Trial Associate or
Some Clinical Monitoring experience and trainings preferred.
Documented training, knowledge and application of current FDA
Regulations, ICH-GCP guidelines in clinical trials required.
Experience developing trial plans including site monitoring,
trial budgets, site selection and clinical supply management.
Proficient written and verbal communication skills.
Ability to collaborate effectively with the study team, cross
functional team members and external partners (including
investigator and site staff).
Therapeutic or medical knowledge and education preferred.
Strong computer skills including knowledge of Excel, Word,
PowerPoint and Outlook.
Experienced in various Clinical Trial Management Systems and
Electronic Trial Master Files management systems
Past experience working for both CRO and Sponsor preferred.
Position may require some travel.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer
committed to a diverse and dynamic workplace.
You have been redirected to a Epizyme job page