Clinical Research Associate - Texas, United States - ML OUTSOURCING SERVICES PRIVATE LIMITED

    ML OUTSOURCING SERVICES PRIVATE LIMITED
    ML OUTSOURCING SERVICES PRIVATE LIMITED Texas, United States

    1 month ago

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    Description

    Title: Clinical Research Associate (Ophthalmology)

    Duration: 24 months

    Location:Remote (however, candidate will need to be in specific states as they may occasionally have to go into the office.)

    States: CA, AZ, IL, WA, IL, NC, FL, SC, GA, NY, TX, MA

    Job Summary

    As a Contract CRA in ophthalmology, you will be responsible for monitoring and managing clinical trials, at the sites under your responsibility, related to eye diseases, ophthalmic treatments, and ophthalmic devices. You will ensure that these trials are conducted in compliance with international guidelines, local regulations, industry standards, and study protocols. This position is regionally based and involves working with multiple clinical trial sites across multiple protocols.

    Key Responsibilities:

    Site Selection and Initiation:

    · Assist in the selection of investigative sites for clinical trials.

    · Conduct site initiation visits to verify that site staff are properly trained and delegated to perform protocol assessments, are familiar with regulatory requirements, and understand proper handling and storage of ophthalmic drugs / devices.

    · Ensure recruitment strategies are in place to meet enrollment targets.

    · Confirm that site meets requirements to begin screening subjects.

    Monitoring and Site Management:

    · Conduct on-site and remote monitoring visits according to the protocol monitoring plan to ensure data quality and regulatory compliance.

    · Review source documents, case report forms, and patient records.

    · Verify the informed consent process is properly executed and adherence to the study protocol.

    · Ensure that instruments / equipment used in the clinical trials are correctly calibrated, maintained, and utilized according to the study protocol and regulatory standards.

    · Collaborate with Clinical Operations Lead and Clinical Trial Team (CTT) to identify and resolve site quality or study execution issues.

    Regulatory Compliance:

    · Ensure that the clinical trial sites are compliant with applicable regulatory requirements (e.g., FDA, ICH, GCP, ISO) regarding ophthalmic drugs / devices.

    · Ensure that study sponsor and Investigator Site File is maintained and audit ready.

    · Assists sites and CTT with internal and external audit / inspection-related activities including preparation, defining CAPAs, and ensuring CAPA targets are met.

    Investigational Product (IP) and Clinical Supplies Oversight:

    · Verify subject qualification and correct IP was dispensed / implanted.

    · Ensure masking has been maintained, if applicable.

    · Confirm full reconciliation of IP at the site level.

    · Monitor drug / device-related safety and performance concerns and report them to the study sponsor.

    · Ensure proper handling, storage, and accountability of investigational drugs and/or devices.

    · Ensures appropriate clinical supplies are available, within expiry date and adequate for clinical trial.

    Data Management:

    · Verify data accuracy and completeness, including instrument / equipment-generated data. Ensure data is securely stored.

    · Collaborate with data management team to resolve data-related issues.

    Safety Reporting:

    · Ensure all safety issues are communicated and managed by the Principal Investigator according to regulatory and protocol requirements.

    Close-Out Visits:

    · Conduct close-out visits to ensure study documentation is complete, finalize data collection, and ensure all study-related activities are completed in accordance with the study protocol and regulatory requirements.

    · Review Investigator obligations.

    Documentation and Reporting:

    · Complete comprehensive and accurate monitoring reports, including site follow-up letters.

    · Ensure CTMS and eTMF are up to date and audit ready.

    Preferred Qualifications:

    · Bachelor's degree in a related field (life sciences, nursing, etc.).

    · Previous experience as a Clinical Research Associate, preferably in ophthalmology or a related therapeutic area.

    · Knowledge of ophthalmic diseases, treatments, and related medical terminology, including ophthalmic devices.

    · Strong understanding of clinical research regulations and Good Clinical Practice (GCP) guidelines.

    · Excellent communication and interpersonal skills.

    · Attention to detail and the ability to work independently and as part of a team.

    · Willingness to travel as needed for on-site monitoring visits.

    · Certification as a Certified Clinical Research Associate / Professional (CCRA / CCRP) or similar credential is a plus.

    EEO:

    "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."