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Remote Clinical Research Monitor(CRA)

San Antonio, TX 78257

Posted: 02/01/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 533681 Is job remote?: Yes Country: United States

Job Description

Pay range 70-85 depending on experience
  • 2 full time resources needed for PACS (Coronary, ENT, Respiratory, Neuro and/or APV experience) Region 1 (Prefer NY, NJ, MD, DE) or Region 6
  • 1 Full time resource with Neuromodulation and cardiac rhythm management experience in Region 2 or 6
  • 3.5 full time resources needed for Diabetes Regions 4, 6, and any other region (one must be from region 4, one must be from region 6, and the others can be located in any region)
  • 1 full time resource for Spine (Region 6)
REQUIREMENTS:
 
  • Candidates must have at least 3 years medical device monitoring experience (nurse or science-related background preferred)
  • Must be able to comply with site covid policies (no exceptions)
  • Must be willing to share covid vaccination status (no exceptions)
  • Must have the ability to travel without restrictions (by air, plane, car, or train)
  • Must be willing to meet via video Zoom or Teams 
  • Must be available to conduct visits upon request with no conflict from other sponsors
  • Remote Monitoring experience preferred
  • CTMS experience preferred,
  • Ability to proficiently navigate multiple electronic systems
  • Excellent organizational, interpersonal and communication skills
  • Expertise in prioritization, problem-solving, time management and planning activities
  • Flexibility with changing priorities
  • Extensive knowledge of federal regulations and demonstrated knowledge of their practical implementation
  • Ability to work on varying projects and exercise critical thinking with minimal oversight

Responsibilities may include the following and other duties may be assigned. Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements. Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval. Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports. May assist with design, development, and monitoring of clinical evaluation projects. Trains investigators and site personnel. Includes headquarter and field clinical research associates (CRA). Implements and prepares the clinical development strategy as outlined by the clinical teams. May contact and recommend qualified investigators to perform studies and initiate clinical trials. Ensures recruitment and retention of patients. 
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