CAREERS AT AMAREX 

We are an equal opportunity employer, offering competitive salaries and excellent benefits. Amarex is currently searching for dedicated and talented individuals for the following positions: 

ACCOUNTING ASSISTANT

Position Summary:

The Accounting Assistant is responsible for supporting the Accounting Department staff to fulfill administrative and accounting responsibilities.

Responsibilities:

  • Assist in tracking and processing pass-through expenses for all projects.

  • Track and report all internal copy expenses, web ex calls, material reimbursements, etc. and prepare for invoicing to sponsor.

  • Maintain spreadsheets and files and produce final PDF for invoicing.

  • Assist with tracking of Independent Contractor invoices.

  • Review monthly invoices.

  • Record client payments.

  • Track, prepare, and submit commission reports.

  • Submit invoices.

  • General filing and scanning of documents as needed.

Required Education and Experience:

  • Bachelor’s degree in an accounting-related field.

  • Strong verbal and written communication skills.

  • Proficient in MS Office software.

  • Ability to work independently with minimal supervision.

  • Ability to work in a team environment, contributing to a collaborative work atmosphere.

SAFETY COORDINATOR

Position Summary:
The Safety Coordinator assists in the processing of Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs) in Clinical Trials and performs Individual Case Safety Reports (ICSRs) processing in the Post-marketing settings.
Responsibilities:

• Enter incoming safety events into related tracking systems and databases
• Handle incoming safety-related reports from clinical trial sites
• Process expedited/non-expedited safety events based on Safety Data Analyst’s evaluation in accordance with company’s SOPs and other regulatory guidelines
• Write SAE narratives
• Perform data reconciliation for ad hoc and annual safety reports
• Organize, attend and take minutes of Safety Department meetings
• Provide administrative/logistical support for the Safety Department
• Other duties, as assigned e.g. assist with medical coding activities

Required Education and Experience:

• RN, Bachelor’s degree in scientific or medical curriculum, or equivalent professional experience
• Competent in the use of Microsoft Office software
• Understanding of medical terminology
• Ability to work effectively both independently and in a team environment
• Strong problem solving and decision making skills
• Strong verbal and written communication skills
• Written communication abilities to include drafting of memos, formatting and taking minutes

SCIENTIFIC PROGRAMMER I

Position Summary:
The Scientific Programmer I is responsible for building programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study's protocol or statistical plans.
Responsibilities:

• Review CRF annotations and data specifications

• Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy

• Build SAS datasets from clinical database

• Test and help to test applications for clinical trial data

• Develop SAS macros, templates and utilities for data cleaning and reporting

• Utilize SDTM guidelines to build datasets

• Identify and edit checks per the data validation plan or data management plan

• Write SAS programs to generate tables, listings, and figures and analysis datasets

• Write, develop, and validate computer programming codes for listings

• Review other programmers programs for tables and graphs

• Work in tandem with Biostatistics and Data Management member on various clinical projects

• Validate the programmed analysis datasets, tables, listing and figures

• Communicate with programming and statistics leads

• Store and retrieve data from databases

• Help to identify programming errors/bugs

• Communicate with an internal team to create deliverables for different projects

• Collaborate with project team and contribute to team efforts

• Other duties as assigned

Required Education and Experience:

• Bachelor’s degree in a related discipline and one year of related software development experience or equivalent education and experience
• SAS programming proficiency
• Strong verbal and written communication skills
• Proficient in MS Office software
• Proficient working knowledge of database management systems
• Accuracy and attention to detail
• Ability to work independently with minimal supervision
• Ability to work in a team environment, contributing to a collaborative work atmosphere

LOGISTICS ADMINISTRATOR

Position Summary:
The primary objective of the Logistics Administrator is to administer, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).  Logistics Administrators also act as pivotal point of contacts & support for the clinical trial team.
Responsibilities:

The Logistics Administrator will be involved in most activities in preparation for study set up, conducting, and completing a Clinical Trial. This includes, but is not limited to:

Primary Trial Master File Duties

• Assume primary responsibility for the setup, development, maintenance, and correspondence of the Trial Master File (TMF) for studies assigned.

• Set up and maintenance Electronic filing systems/set up of the Investigator Site File (ISF).

• Track Ethics/Regulatory submissions & approvals for studies.

• Prepare distribute, track, and file essential clinical trial documentation.

• Coordinate archiving of study documentation.

CRA and Study Team Support

• Assist the Clinical Team Leads and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines

• Point of Contact for CRA assistance with TMF or study related material support

• Arrange & participate in the organization of Investigator Meetings & Study Team Meetings including taking and distributing minutes and tracking of the final document

Study Management Support

• Assist the Clinical Project Manager and Clinical Team Leads in site selection process

• Assist in initial composition of Operations Manual, Pharmacy Binder, and Investigator Site File (ISF) Binder etc.

• Manage and maintain study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites

• Ensure that any clinical trial databases/tracking tools are set up and maintained throughout the trial

• Create & maintain study contact lists for team/sites/3rd parties

• Review study mailbox and file emails in appropriate mailbox folders

• Assist in preparation and distribution of Study Newsletters /Study Correspondence to all participating sites on an ongoing basis

• Set up of finance systems accurately, process invoices and track payments for the trial for investigator and vendor payments

• Assist with collating, tracking & shipping CRFs & data queries to Data Management

• General study filing

Other possible tasks may include:

• Assisting with designing of study logs, source document template etc.

• Arranging translation of advertisement material and patient documents

• Assisting Clinical Research Associates on monitoring visits

• Re-ordering clinical drug supplies for sites

• Other duties as assigned

Required Education and Experience:

• Bachelor’s degree

• Proficiency in verbal and written communication skills

• Strong MS Office skills

• Extremely detail-oriented with excellent follow-up skills

• Ability to work independently with minimal supervision

• Effective interpersonal skills, including the ability to work in a team environment, contributing to a collaborative work atmosphere

SAFETY DATA ANALYST

Position Summary:
The Safety Data Analyst processes Adverse Event (AE) and Serious Adverse Event (SAE) cases promptly and with medical accuracy.  The Safety Data Analyst will also assist the Supervisor with Medical Coding and Medical Monitoring activities and overseeing the overall conduct of pre- and post-marketing studies with regard to Safety of the subjects.
Responsibilities:
• Develop Clinical Safety, Medical Coding and Medical Monitoring plans
• Code medical data including medications (utilizing WhoDrug), adverse events and serious adverse events (utilizing MedDRA)
• Process, document, and report information on Adverse  and Serious Adverse Events to the client and the FDA
• Prepare safety narratives
• Prepare safety case reports to the FDA and regional regulatory agencies using MedWatch and CIOMS-I forms, and annual/periodic safety reports 
• Maintain, review and reconcile safety database and clinical databases for paper based studies.  Evaluate safety trends and pharmacovigilance risk assessment in collaboration with the biometrics

   department according to the Scope of Work
• Participate in sponsor audits as required
• Participate in project team meetings as required
• Communicate orally and/or written, in a timely and effective manner, with the appropriate internal or external individuals involved in the project  
• Assure that the required study documents are complete, accurate and in accordance with required global and region-specific regulations and guidelines 
• Provide support for the audits of clinical sites according to the Scope of Work
• Participate in the Data Safety Monitoring Committees (DSMC), providing and presenting safety and pharmacovigilance reports for DSMC meetings for various sponsors, if applicable

Required Education and Experience:

• Medical Degree or Graduate research- based degree in medical sciences
• Familiarity with global and region-specific regulations and guidelines
• Knowledge of adverse event processing environments such as ARISg or similar is preferred
• Excellent English reading and writing skills to facilitate complete and concise safety reporting 
• Competent in the use of Microsoft Office software
• Excellent verbal communication skills
• Good interpersonal skills and ability to work in a team environment contributing to a collaborative work atmosphere

INFORMATION TECHNOLOGY ADMINISTRATOR

Position Summary:
The IT Administrator is responsible for the support, performance, and functionality of the system environment, including end user support, upgrades, customization, and system integration.
Responsibilities:
• Ensure data is backed up on a regular basis
• Oversee general administration of Windows desktop applications. Carry out computer “housekeeping” tasks – including migrations, patches, and upgrades
• Deploy new workstations/laptops to users
• Provide IT support to end users, both on- and off-site. resolving the problem if possible, with an appropriate sense of urgency
• Troubleshoots and solves network connectivity problems, including monitoring the network and servers for problems, diagnosing problems, and taking the appropriate corrective measures to ensure 

   an expedient resolution
• Install, administer, support, and maintain server hardware, peripherals, software, and operating systems
• Provide input into IT strategy and acceptable use policy
• Keep abreast of IT technology
• Other duties as assigned

Required Education and Experience:

• Bachelor’s degree and two (2) years of related experience or equivalent education and experience
• Understanding of IT systems best practices, including the documentation and testing of systems
• Expertise in maintaining MS Windows desktop/server installations
• Strong technical knowledge of MS Exchange, SQL Server, VMWare and Office is required
• Experience in Acronis TrueImage, PDQ Deploy, Symantec EndPoint Protection, and Unitrends Recovery is desired
• Ability to work overtime when necessary
• Ability to work independently with minimal supervision
• Strong problem-solving skills and the ability to develop alternative solutions
• Strong customer-service orientation which includes effective interpersonal skills and the ability to work in a team environment

IT HELP DESK TECHNICIAN LEVEL 1

Position Summary:
The IT Help Desk Technician Level 1 is responsible for end user support, upgrades, customization, and system integration.
Responsibilities:
• First point of contact for troubleshooting of IT problems; resolving the problem if possible, with an appropriate sense of urgency. Provide IT support to end users, both on- and off-site
• Provide IT systems orientation to new staff members
• Install, test and configure new workstations, peripheral equipment and software
• Provide mobile and IP telephony phone support
• Online services administration and support (electronic signatures, e-mail security, file sharing, mobile devices, online meeting, etc.)
• Develop instructional documents
• Perform timely workstation relocation as required
• Keep abreast of IT technology
• Other duties as assigned
Required Education and Experience:

• Bachelors degree and one (1) year of related experience or equivalent education and experience
• Understanding of IT systems best practices, including the documentation and testing of systems
• Expertise in maintaining MS Windows desktop  installations
• Experience in Active Directory, Microsoft Exchange, Microsoft Office, mobile OS (iOS & Android), and PDQ Deploy
• Ability to work overtime when necessary
• Ability to work independently with minimal supervision
• Strong problem-solving skills and the ability to develop alternative solutions
• Strong customer-service orientation which includes effective interpersonal skills and the ability to work in a team environment

 

CLINICAL DATA COORDINATOR (two openings)

Position Summary:
The Clinical Data Coordinator is responsible for timely validation of clinical trial data.
Responsibilities:
• Review and validate clinical trial data.
• Review case report forms and clinical data sets for errors, discrepancies and protocol violations
• Ensure timely completeness and accuracy of databases
• Adhere to company procedures related to data handling & data base validation
• Implement data entry conventions
• Organize and maintain clinical study databases to support regulatory submissions
• Design case report forms and related data entry applications
• Maintain a thorough understanding of regulatory requirements for data processing operations
• Organize and track CRFs, project documents, supplies and enrollments
• Participate in project team meetings and recommend processes that lead to timely and successful completion of administrative tasks
• Communicate orally and/or written, in a timely and effective manner, with the appropriate internal or external individuals involved in the project
• Review case report data and interface with study team to resolve data queries
• Other duties as assigned
Required Education and Experience:
• Bachelor’s degree and one year of related experience
• Accuracy and attention to detail
• Strong MS Office skills
• Strong organizational skills with ability to manage multiple projects
• Experience with clinical trials data and knowledge of CFR guidelines and GCP preferred
• Ability to work independently with minimal supervision
• Effective interpersonal skills, including the ability to work in a team environment, contributing to a collaborative work atmosphere

PROGRAMMER ANALYST I

Position Summary:

The Programmer Analyst I is a computer programming position responsible for delivering technical services relating to clinical trials data. This includes working with Electronic Data Capture (EDC) and other data management applications to achieve project integrity and the delivery of on-time, quality data. The Programmer Analyst I analyzes the feasibility of program requirements to develop applications that meet FDA guidelines.

Responsibilities:

  • Identify, evaluate and solve clinical data collection problems

  • Develop and implement clinical data collection methods that meet FDA guidelines

  • Test, document, and validate clinical data collection computer systems

  • Develop user manuals

  • Demonstrate and train users on the application

  • Support user acceptance testing

  • Provide maintenance for user requested changes to the application/database

  • Provide support for proprietary data management computer applications

  • Other duties as assigned

Required Education and Experience:

  • Bachelor's degree in computer science or related field of study and 1 year of related experience OR equivalent education and relevant experience

  • Working knowledge of relational databases (Postgres, SQL Server)

  • Working knowledge of ASP .NET, C#, IIS, Java, J2EE, JavaScript/JScript, and Visual Basic .NET

  • Strong verbal and written communication skills

  • Extremely detail-oriented with excellent follow-up skills

  • Ability to work independently with minimal supervision

  • Effective interpersonal skills, including the ability to work in a team environment, contributing to a collaborative work atmosphere

To submit your CV for our consideration, please email us at jobs@amarexcro.com.

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