Why CTRG?

Join a fast-growing, dynamic, exclusively clinical-stage CRO partnering with sponsors developing new pharmaceuticals or medical devices. We bring together top minds in the industry to develop, coordinate and complete human clinical trials of all phases and sizes in the ophthalmology space.

You’ll be supported by a strong team with multiple years of ophthalmology-specific clinical trial experience, and gain exposure to a field focusing on the treatment of the most common causes of blindness.

A career with CTRG means you’ll be a part of the mission to improve vision for patients around the world.

 
 
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Job Listings

To apply, please send resumes to info@ctrgresearch.com

Clinical Research Associate (on-site and remote)

JOB SUMMARY

We are currently looking for an experienced CRA to join CTRG. In this role you will be covering sites in the US.

JOB RESPONSIBILITIES

  • Performs site qualification, site initiation, interim monitoring, site management and close-out visits

  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.

  • Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

    • Assesses site processes

    • Conducts Source Document Review of appropriate site source documents and medical records

    • Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records

    • Applies query resolution techniques remotely and on site

    • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture

    • Verifies site compliance with electronic data capture requirements

    • May perform investigational product (IP) inventory, reconciliation and reviews storage and security.

  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness

  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan

  • Understands project scope, budgets, and timelines for own and others’ activities in the clinical team

  • May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate

  • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings

  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions

  • May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned

  • May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager

QUALIFICATION REQUIREMENTS

We are looking for enthusiastic new colleagues with the following:

  • Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution with significant clinical research monitoring experience (comparable to at least 3-5 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.

    In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.

Knowledge, Skills and Abilities:

  • Effective clinical monitoring skills

  • Excellent understanding and demonstrated application of FDA/EMEA and preferably some Latin American/South American guidelines, Good Clinical

  • Practices and applicable Standard Operating Procedures

  • Ability to mentor and train other monitors in a positive and effective manner

  • Ability to evaluate medical research data and proficient knowledge of medical terminology

  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

  • Strong customer focus

  • Excellent interpersonal skills

  • Strong attention to detail

  • Effective organizational and time management skills

  • Proven flexibility and adaptability

  • Excellent team player with team building skills

  • Ability to work independently as required

  • Ability to utilize problem-solving techniques applicable to constantly changing environment.

  • Good computer skills

  • Good knowledge of Microsoft Office and the ability to learn appropriate software

  • Effective presentation skills

  • Therapeutic expertise Ophthalmology a plus

  • Ability to manage required travel of up to 10-40% on a regular basis