Atlantic Research Group's success is a direct result of its dedicated, motivated, and highly trained staff. Our work culture is a balance of challenging science and problem solving with a relaxed environment that rewards both teamwork and individual efforts. ARG offers competitive salary and incentive programs, a comprehensive benefit package and complete support from our managing partners. ARG is committed to its employees, and realize they are the nucleus to each project's success.
Clinical Research Associate performs and coordinates all aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Also, represents Atlantic Research Group in the medical research community and develops collaborative relationships with investigative sites and client company personnel. Required to travel 50-80% on average.
Education:
-Bachelor’s degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution (i.e.: RN, MT, PA, RPh, RT)
Experience:
-Previous Study Coordination a plus
-Minimum one year as an on-site clinical monitor
Skills:
-Demonstrated clinical monitoring skills
-Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs
-Thorough understanding of medical terminology
-Computer skills and ability to learn and become proficient with ARG software
-Excellent oral and written communication skills
-Strong client and customer service skills
-Demonstrated attention to detail
-Demonstrated flexibility and adaptability
-Ability to work in a team environment and independently as needed
-Therapeutic experience in Oncology, Immunology, Phase I-III trials a plus
Project Manager
The Project Manager is responsible for the overall coordination and management of clinical trials from initiation phase through close out activities. Manages the design, implementation, and delivery and reporting of clinical research programs, ensuring each is within budget and timelines. Acts as the primary contact for all assigned clients. Serves as the primary point of contact for sales and operations. Responsible for scheduling, tracking and managing clinical research programs and milestones. Responsible for continual relationship management between the client and ARG. Manages day to day activities and provides guidance to assigned clinical team members. Responsible for feasibility, site selection, and conduct of all trials. Manages scope of study and provides operational guidance to facilitate the proposal generation process. Generates status reports and summarizes data for month-end reports as required. Negotiates resolutions to conflicts over scope definition, deliverables, clinical issues, and schedules.
Experience:
-Minimum 5 years experience in clinical research and clinical project management. Previous on-site monitoring experience helpful
Education:
-Bachelor’s degree or licensed certified health care training or equivalent combination of education and experience
Skills:
-Demonstrated problem solving, judgment and decision making skills
-Excellent oral/presentation and written communication skills.
-Demonstrate organizational and negotiation skills.
-Knowledgeable of FDA, ICH and GCP guidelines
-Demonstrated experience in SOP and process creation
-Demonstrated Leadership skills
-Possess good interpersonal skills, self-motivated, and retains a positive attitude.
-Demonstrated knowledge of applicable computer systems
Trial Site Manager
The Trial Site Manager assists in the management and support of the clinical operations team with regards to study start-up, clinical status tracking, and in-house clinical operations management. Ensures all tasks meet ARG SOPs and are in accordance with ICH/GCP guidelines. Serves as primary liaison for start up and in-house site management issues.
Experience:
Previous experience as a research coordinator or investigative site liaison. Previous CRO experience or clinical research industry experience a plus.
Education:
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution
Skills:
-Demonstrated ability to manage and conduct routine reviews of essential regulatory documents
-Demonstrated ability to create and maintain the Trial master File
-Ability to track and review tasks, timelines, and clinical tasks
Ability to interact with other clinical team members
-Demonstrated ability to provide timely status reports for the clinical activities on assigned projects
-Demonstrated knowledge of applicable computer systems
Quickbase Developer
The Quickbase Developer will support the development and management of the ARG TrialVista system, as well as, any custom solutions for ARG's clients.
Experience:
Previous experience in Quickbase development is a must. Also experience programming Javascript and/or Ruby (with or without Rails) is desired. Previous CRO experience or clinical research industry experience a plus.
Education:
Undergraduate degree or its international equivalent from an accredited institution
Skills:
-Demonstrated understanding of databases and their design
-Demonstrated ability to develop intuitive interfaces within the Quickbase environment
-Ability to think creatively and show leadership in the development of client solutions
-Ability to interact with other team members
-Ability to work with users of all skill levels and help them learn the given product or products.
-Ability to effectively process user feedback and incorporate it into future versions of the software
