Clinical Research Associate (In-house)
Company: Beacon Hill Staffing Group - Pharma
Location: Quincy
Posted on: February 13, 2021
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Job Description:
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.
Keywords: Beacon Hill Staffing Group - Pharma, Quincy , Clinical Research Associate (In-house), Healthcare , Quincy, Massachusetts
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