Clinical Research Associate (on-site and remote)

JOB SUMMARY

We are seeking an experienced Clinical Research Associate (CRA) to join our CTRG. In this role, you will oversee sites across the United States, ensuring compliance with study protocols, GCP guidelines, and regulatory requirements. This position requires a strong background in ophthalmology trials, meticulous attention to detail, and the ability to travel up to 80% of the time to support our site teams.

QUALIFICATION REQUIREMENTS

  • Bachelor's degree in a science related field 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:

  • Therapeutic expertise in Ophthalmology is a must.

  • Ability to manage required travel of up to 60-80% travel, with an average of 8-10 days on site, sometimes including additional remote visits.

  • Effective clinical monitoring skills.

  • Excellent understanding and demonstrated application of FDA/EMEA, 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.

  • Strong oral and written communication skills, with the ability to effectively engage with medical personnel and cross-functional teams.

  • High level of customer focus and responsiveness.

  • Excellent interpersonal skills with the ability to build strong working relationships.

  • Exceptional attention to detail and accuracy.

  • Effective organizational and time management abilities to handle multiple priorities.

  • Proven adaptability and flexibility in a dynamic work environment.

  • Collaborative team player with strong team-building capabilities.

  • Ability to work independently with minimal supervision when needed.

  • Skilled in applying problem-solving techniques in a constantly changing environment.

  • Proficient computer skills, with strong knowledge of Microsoft Office and the ability to quickly learn new software.

JOB RESPONSIBILITIES

  • Responsible for all aspects of monitoring clinical trials in accordance with ICH/GCP and FDA guidelines, company SOPs, scope of work, and other contractual obligations.

  • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.

  • Monitor the progress of clinical studies at investigative sites and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

  • Ensure the rights, safety, and welfare of trial subjects is maintained.

  • Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.

  • Assess the safety and efficacy of investigational products and/or medical devices.

  • Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.

  • Assesses IP accountability, dispensation, and compliance at the investigative sites.

  • Provides regular site status information to team members, trial management, and updates trial management tools.

  • Functions as the first point of contact for investigator sites, providing guidance on the protocol and applicable regulatory requirements.

  • Performs essential document site file reconciliation.

  • Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.

  • Ensure that all study-related documentation is tracked, printed, and filed as required by SOPs, regulatory requirements, and other protocols.

  • Communicate effectively with project team members to ensure study completion per company and client requirements and timelines.

  • Proactively communicate with study sites and follow-up on all open issues to meet the project timelines.