6 days left
- Full Time
The EMMES Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, 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 offer statistical support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Emmes is seeking a Protocol Specialist
ProjectThis position will support the NIDA CCC, National Institute on Drug Abuse Clinical Coordinating Center, which has responsibility for protocol development, regulatory oversight, protocol and safety monitoring, on site clinical monitoring and study maintenance for the Clinical Trial Network (CTN) which NIDA supports. Many of these activities are carried out by protocol specialists, including coordinating pharmacy and lab support throughout the study, providing regulatory support and general support to protocol teams, Nodes/University centers, and research sites during protocol development, initiation, implementation, and close-out. The NIDA CTN -is a national network of research sites conducting studies of behavioral, pharmacological, and integrated treatment interventions in rigorous, multi-site clinical trials. The objective is to “bridge the gap” between science and practice by conducting the trials on the research sites. The NIDA CTN is comprised of 13 university centers (Nodes) associated with approximately 240 research sites and other research networks.
- 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 CCC team in doing so as appropriate
- Critically review and comment on study protocols, informed consents and other study documents as needed
- Review site visit reports prepared by Protocol Monitors for site or study wide issues
- Collect and review regulatory documents and advise the protocol teams on sponsor regulatory requirements
- Collaborate with internal and external team members to improve study conduct, monitoring and assure compliance with study procedures
- Responsible for approximately two or three different protocols
- Participate on conference calls with Protocol Teams during development and implementation stages offering assistance and guidance as appropriate
- Seek and develop internal and external resources to assist you in accomplishing your goals
- Develop rapport and strong, productive relationships with NIDA contacts and protocol operations team
- Willing and eager to seek out creative and innovative resolutions to issues or problems and think strategically
Bachelor’s degree in a scientific discipline or equivalent experience
1-2 years of monitoring or study coordinator experience preferred
Skills in prioritization, problem solving, organization, decision-making, time management and planning
Prior knowledge of GCP, HSP and regulatory guidelines and regulations helpful
Detail oriented, excellent presentation, oral and written communication skills required
Ability to function effectively on a team, providing and receiving constructive feedback
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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.