Clinical research specialist serp_jobs.h1.location_city

In-House Clinical Research Associate I

Hybrid : Onsite Monday - Wednesday

Top Required Skills :

Medical Device experience or Ophthalmology

1-3 years' experience as a CRA, preferably in-house

Summary

The In-House CRA I is based in the client's facility and will provide clinical research support and assistance in overseeing the conduct of clinical trials.

RESPONSIBILITIES

Work to ensure that trials are adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (GCP) guidelines, and government regulations.

Evaluate, monitor, and document study results.

Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and sponsor representatives.

Monitor Clinical Research Organizations (CROs) and study management of multiple sites.

Additional duties include : document retrieval, archival, informed consent release forms, amendments, etc.

Responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome, investigator and study staff training.

Ensure procedures are in place for appropriate optimization of patients into the clinical trial.

Planning the requirements for clinical trial material (CTM), ordering CTM, setting up and monitoring the systems whereby the CRA can ship CTM to the investigator, maintaining procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.

Approximately 15% local on-site co-monitoring

QUALIFICATIONS

Bachelor's degree required

1-3 years combined experience with at least one of the following :

Medical device research experience

In-house pharma CRA experience (strictly Regional CRA experience will be considered)

Clinical Research Coordinator (site-level Study Coordinator) experience is required in lieu of CRA experience

On-site monitoring experience is preferred but not required

Electronic Data Capture (EDC) experience required (non-discriminatory)

Excellent oral and written communication skills

Willingness to travel up to 15% (as-needed basis, not continuous basis) in Southeast US for intermittent monitoring

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