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ARG is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. ARG also complies with all work authorization and employment eligibility verification requirements and is an E-Verify employer.


Successful candidates must complete a background, social media and/or credit check.


If you would like to request an accommodation associated with the hiring process because of a medical condition or disability, please send an email to hr@atlanticresearchgroup.com or call 434-202-4785.


Please submit your CV/cover letter if you would like to join the ARG team.


Clinical Data Manager


Description

The Clinical Data Manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.


Responsibilities

The Data Manager is responsible for providing data management support to the Project Manager, Clinical Operations team, Drug Safety and Biostatistics. Specific tasks include:

-Participates in the review of clinical research documents. 

-Manages the clinical database validation lifecycle.

-Develops and maintains Data Management Plan(s) (DMP), and ensures compliance with the DMP through the study lifecycle.

-Responsible for developing the electronic case report form (eCRF), database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
-Leads EDC database (DB) specification process and User Acceptance Testing (UAT).

-Develops Data Transfer Agreement between external data vendors and reconciles electronic data transfers from vendor to Sponsor.
-Creates EDC completion guidelines and manages the Data Management Study File for assigned projects.
-Ensures clinical data within EDC is clean and/or complete and ready for database lock or freeze as appropriate for statistical review, interim review or final database lock.

-Assists in defining or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review or data management audit.
-Assists in reconciling AE/SAE data in Safety DB with the clinical database.
-Coordinates the archiving of study databases and related documents.

-Performs close-out activities for study database as required.

-Assists and provides input into study and project level data analysis plan.
-Collaborates with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.

-Participates in the preparation and presentation of data, when applicable.
Ensures data system compliance by following the established guidelines of national and international regulatory authorities.

-Participates in conference calls with Project teams and/or meetings with vendors.







Requirements

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: At least 5 years experience in data management with at least 2 years experience as a data manager in a clinical research setting.


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Clinical Research Associate


Description

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.


Responsibilities

The CRA will represent 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.


Requirements

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


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Project Manager


Description


Project managers can have the responsibility of the planning, execution and closing of the clinical trial. They oversee the work of the project team as well as communicate to the sponsor, site, and vendors.


Responsibilities

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.


Requirements

Experience:
-Minimum 5 years experience in clinical research and clinical project management. Previous on-site monitoring experience helpful
Education:
-Bachelors 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


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Trial Site Manager


Description

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.


Responsibilities

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.


Requirements

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


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TrialVista Developer


Description

The TrialVista Developer will support the development and management of the ARG TrialVista Clinical Trial Management System (CTMS) as well as any custom solutions for ARG's clients.


Responsibilities

Quickbase database architecture, including table design, form creation, and administration. Establish SOPs for upgrading and maintaining TrialVista and related software systems.


Requirements

Previous experience in Quickbase development is a must. Experience with other SaaS solutions (e.g. Salesforce) is applicable. Also experience programming Javascript and/or Flex 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


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Quality Assurance Auditor


Description

A Quality Assurance Auditor is responsible for conducting various types of routine and for cause audits including, but not limited to: site audits, trial master file audits, vendor audits, internal process audits, and database audits and documenting these audits within ARG’s Clinical Trial Management System, TrialVista.


Responsibilities

Auditor will conduct audits to ensure compliance to local and federal regulations, ICH GCP, protocol and, where applicable, ARG or Sponsor SOPs. Auditor may assist in audit preparation prior to third party and regulatory audits. Works under limited supervision, reporting to the Director of Quality Assurance and Monitoring and participates in project team audit follow up meetings to develop appropriate resolution plans or CAPAs. Serves as a regulatory reference for Sponsors and ARG staff. May assist Director of Quality Assurance in QA SOP development and other quality management activities. Travel may include 1-3 audits per month in US and international locations.


Requirements

Education:
-BA, BS or MS in bio-scientific, health care or life sciences.

Experience:
- Previous auditing training and/or experience required
- Experience as an on-site clinical monitor desired.


Skills:
- Superior clinical auditing and monitoring skills
- Excellent decision making skills and sound judgment
- Current and working knowledge of Federal Regulations, ICH /GCP and applicable SOPs
- Thorough understanding of medical terminology and human physiology (willingness to review and learn indications as background for each clinical study)
- Computer skills and ability to learn and become proficient with ARG Clinical Trial Management System (TrialVista) and Microsoft Office
- Excellent oral/presentation and written communication skills.
- Ability to complete tasks efficiently and resolve problems within set timelines
- Excellent client and customer service skills
- Strong organizational skills and attention to detail
- Demonstrated flexibility and adaptability
- Ability to work in a team environment and independently as needed
- Willingness to assist with tasks not specifically outlined in this description


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Drug Safety Specialist


Description

The Drug Safety Specialist is responsible for the overall coordination and management of individual case safety reports (ICSRs), data entry, reconciliation, coding, and expedited reporting for projects including the generation and management of all associated safety project plans.


Responsibilities

- The DSS will serves as Lead Drug Safety Specialist for small projects or as a part of a team of Safety Specialists, serves as the drug safety point of contact for study teams.
- The DSS will be responsible for preparing safety management plans and related documents and templates, performing all aspects of data entry including coding of events, determination of labeling, reportability, QC and completing cases within required timelines.
-The DSS should have the ability to prepare and submit expedited and periodic reports to governing bodies according to regulated timelines and formats.


Requirements

Education
- BA or BS, preferably in life sciences or health care
- RN, BSN, or MS preferred, but not required

Experience
- 2-4 years of related experience in drug safety, pharmacovigilance and/or device reporting
- Experience with Device reporting desired
- Experience with regulatory document submission
- Eudravigilance training and registration a plus

Skills
- Self-starter with strong interpersonal and organizational skills and able to work with some supervision to achieve objectives in a timely manner
- Ability to prioritize work, exhibit high degree of accuracy, and meet deadlines in a highly dynamic environment
- Knowledge of relevant international regulations/guidelines and strong understanding and usage of medical terminology preferred
- Thorough understanding of medical terminology and human physiology (willingness to review and learn indications as background for each clinical study)
- Excellent oral/presentation and written communication skills
- Ability to complete tasks efficiently and resolve problems within set timelines
- Excellent client and customer service skills
- Demonstrated flexibility and adaptability
- Ability to work in a team environment and independently as needed
- Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems

Candidate must be a US citizen or permanent resident.


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