To provide clinical support for projects according to Standard Operating Procedures, ICH Guidelines and GCP.
- To develop and/or maintain tracking systems for clinical projects.
- Responsible for all aspects of study site monitoring with or without direct supervision (as per the training status of the CRA I MEA).
This includes remote and/or onsite conduct of pre-study visits, site initiation visits, routine monitoring visits and close-out visits of clinical sites.
- Conduct site management activities, maintain study files, liaise with vendors; perform other duties, as assigned.
- Responsible for aspects of registry management as prescribed in the project plans.
- General On-Site Monitoring Responsibilities per the monitoring plan to include those indicated.
For ONSITE, Assist Sr.
In-House Clinical Research Associate (Sr. IHCRA), Clinical Research Associate 1 (CRA1) with 1+ years of independent monitoring experience, Clinical Research Associate 2 (CRA 2), Senior Clinical Research Associate 1 (Sr. CRA 1) and Senior Clinical Research Associate 2 (Sr. CRA 2) with on-site tasks as required and according to training goals (e.g.
review of Case Report Forms, SDR/SDV, Site Regulatory File and drug accountability).
All activity to be conducted under direct supervision of the primary monitor, until Evaluation Sign-Off visit is successfully completed for the CRA I MEA.
For REMOTE, Perform remote visits (i.e.
Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan including remote monitoring that requires SDR/SDV after successful completion of the MEA training program.
- Ensure the resources of the Sponsor and organization are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy.
- Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on organization or client data management systems, as assigned by management.
- Track and follow-up on serious adverse events as assigned.
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- Responsible for all aspects of site management as prescribed in the project plans.
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Ensure audit readiness at the site level.
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
- Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE.
- Travel, including air travel, may be required and is an essential function of the job.
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