Protocol Specialist

Location
Rockville, Maryland
Posted
Apr 05, 2019
Closes
Apr 05, 2019
Function
Other
Industry
Science
Hours
Full Time
The Emmes Corporation, established in 1977, is a privately-held, woman-owned private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trial conduct, from study design and protocol development through data analysis and manuscript generation. Emmes is searching for two experienced Protocol Specialists to support the AIDS Malignancy Consortium project and can be located in our Frederick or Rockville offices.

Project

The AIDS Malignancy Consortium (AMC) group focuses on innovative Phase I through III clinical trials for the treatment of AIDS-related cancers and malignancies that occur in people living with HIV/AIDS. The AMC group provides support for more than 20 clinical research studies both domestically and internationally. The AMC is a full-service project that provides multi-faceted support such as data management, protocol monitoring, adverse event review and reporting, protocol development, and regulatory document tracking and submission.

Responsibilities

    Utilize project management tools and practices to coordinate the development of new protocols including developing necessary documentation (Operations Manuals, Standard Operating Procedures, and other required documentation) with the protocol development team, managing timelines (concept development, initiation, implementation and closeout) and other tasks as needed Meet deadlines for deliverables to sponsor and assist the rest of the project team in doing so as appropriate Critically review and comment on study protocols, informed consents and other study documents as needed Support resolution of site or study-wide issues with Protocol Monitors for site visits and/or audits Serve as backup support for regulatory audits and occasional review of IRB approvals for clinicaltrials.gov postings/other purposes Collaborate with internal and external team members to improve study conduct, monitoring and assure compliance with study procedures Responsible for several protocols at varying stages in the trial life cycle Participate on conference calls with protocol teams during development and implementation stages, offering assistance, guidance, and drafting/editing support as appropriate Manage website listings for assigned protocols (public/private group website and clinical trial registries) Seek and develop internal and external resources to assist in accomplishing the goals of the project Develop rapport and strong, productive relationships with project stakeholders and protocol operations team
Experience

    Bachelor’s degree in a scientific discipline or equivalent experience Minimum 2 years of monitoring, study coordinator, or other clinical trials experience Skills in prioritization, problem solving, organization, decision-making, time management and planning Prior knowledge of GCP, HSP, regulatory requirements and guidelines helpful Detail oriented; excellent presentation, oral and written communication skills required Ability to function effectively on a team, providing and receiving constructive feedback with persons of all experience levels

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs

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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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