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Clinical Research Associate (in-house)


  • Beacon Hill Staffing Group - Pharma
  • 10/08/19
  • Newton, MA
  • 02458
  • 55 / Hourly
  • Contractor
SUMMARY:
Oversees the progress of clinical investigations by conducting pre-study, initiation, interim and close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices. Works closely with the Clinical Project Manager to ensure all monitoring activities are conducted according to study requirements.
RESPONSIBILITIES:
Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.
Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested.
Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials including submission if required
Performs study initiation activities; reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF.
Conducts periodic site file audits to ensure compliance with GCPs and accuracy of Trial Master File aAssures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Prepares monitoring reports and letters in a timely manner in accordance with the study monitoring plan.
Performs investigational product inventory. Verifies destruction of unused materials or ensures return to designated location, as required.
Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
Serves as primary contact between Karyopharm and investigator Participates in study team meetings providing monitoring updates.
Assists with, attends, and may present at Investigator Meetings for assigned studies.
Performs study close-out visits.
May request site audits for reasons of validity.
Performs other duties as requested.
Up to 75% domestic and/or international travel may be required.

QUALIFICATIONS:
Bachelor's degree or nursing qualification is required. Scientific/health care field preferred, but not required.
Experience (1+ years) working in clinical research within a pharmaceutical company, CRO or similar organization.
Strong knowledge of clinical research process and medical terminology.
Understanding of GCP/ICH guidelines.
Knowledge of regulatory requirements and guidelines governing clinical research.
Understanding of basic data processing functions, including electronic data capture.
Strong knowledge of MS Word, Excel, PowerPoint and Outlook.
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization.
Ability to reason independently and recommend specific solutions in clinical settings.
Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
Ability to work successfully within a cross-functional team.


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