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In-house Clinical Research Associate (iCRA)

Company: Epizyme, Inc.
Location: Cambridge
Posted on: September 16, 2020

Job Description:

In-house Clinical Research Associate (iCRA) Clinical Operations Cambridge, Massachusetts

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, visit www.epizyme.com.

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.

Key Responsibilities:

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 visit trackers;

Review monitoring reports and help track issues and data trends at sites;

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 systems.

Education & Requirements:

Bachelor’s or associates degree in health sciences or related field.

Minimum of 2-3 years’ experience in clinical research with at least 1-2 years’ experience as a Clinical Trial Associate or similar position.

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.

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Keywords: Epizyme, Inc., Cambridge , In-house Clinical Research Associate (iCRA), Other , Cambridge, Massachusetts

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