Sr. Clinical Research Associate (Sr. CRA/In-house/Sponsor Side) - Marlborough, MA | Biospace
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Sr. Clinical Research Associate (Sr. CRA/In-house/Sponsor Side)

Astellas

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Location:
Marlborough, MA
Posted Date:
9/11/2017
Position Type:
Full time
Job Code:
01752
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations,

Job Description

Description:

•   The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

•   Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

•   AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both hESC and induced pluripotent stem cells -- and other cell therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.

Purpose & Scope:

NOTE: THIS IS NOT A HOME-BASED or REMOTE POSITION. THIS IS AN IN-HOUSE/ON-SITE/SPONSOR SIDE SR. CRA POSITION IN MARLBOROUGH, MA 01752.

•   The Sr. Clinical Research Associate will assist the Lead Study Manager and the clinical team in the day to day activities for managing clinical study conduct to support completion per established project team goals and objectives. The scope of this position is Phase I through 4 clinical studies including registries and observational studies.

Essential Job Responsibilities:

•   Lead the day to day support of study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study.
•   Conduct and/or oversee clinical monitoring (site qualification, site initiation, interim monitoring, study closeout visits) activities to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. May included monitoring visit report review and/or participating in co-monitoring visits.
•   Assist in study set-up including but not limited to eCRF design, protocol preparation, informed consents, investigator selection, systems (e.g., CTMS), study related operational manuals, training materials, and various study plans (e.g., visit logs, monitoring plan, etc.).
•   Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study related activities as needed.
•   Collaborate with cross-function study team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and AIRM SOPs.
•   Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and. or submission of regulatory documents to the TMF and ongoing document reconciliation.
•   Assist in maintaining accurate and up to date study information within CTMS and other relevant tracking systems
•   Effectively communicate with study team members and work closely with Lead Study Manager to address challenges.
•   May participate in process improvement and quality-related initiatives associated with study execution and deliverables
•   Responsible for complying with regulations and guidelines and ensuring adherence to these during study conduct.
•   Travel Required: up to 25%

Requirements


Requirements:

Required:

•   BA/BS with 4-8 years clinical research experience, or MA/MS with 2-6 years clinical research experience
•   Ability to work independently under general direction in a fast-paced environment
•   Minimum of 2 years prior clinical monitoring experience
•   Must have excellent interpersonal, written, verbal, presentation, administrative and computer skills
•   Fluent in English (oral and written)
•   Moderate (25%) travel required.

Preferred:

•   Ophthalmology experience
•   Cell-based products/biologics clinical trial experience Disclaimer

The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled.