The Regional Clinical Research Associate completes project activities associated with monitoring functions of Phase I-IV clinical research studies. This individual performs investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).
Responsibilities include (but are not limited to) :
Performs study start-up activities related to monitoring activities.
Develops and implements innovative approaches for and participates in site recruitment, selection, and initiation activities.
Participates in CRA protocol specific training and development activities.
Develops and implements innovative approaches for the preparation and coordination of investigator meetings and participates in meeting.
Conducts site initiation visits with study site staff (train site personnel in GCP and study conduct)
Develops patient enrollment strategies with the project team and clinical trial sites.
Ensures the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
Ensures proper storage, dispensation and accountability of clinical trial materials.
Conducts interim monitoring visits (conducts source document verification of CRF against medical records).
Performs site management activities.
Conducts in-house monitoring activities as appropriate.
Review investigator regulatory files to ensure they are accurately maintained.
Maintains patient tracking records for assigned sites.
Conducts study site close-out visits.
Completes administrative activities as a member of the project team.
Knowledge, Skills, and Abilities:
Excellent verbal and written communication skills
Excellent organizational, record retention, and time management skills
Excellent decision making skills
Excellent customer service and interpersonal skills
Knowledge of FDA regulatory requirements (i.e. GCPs, CFRs, etc.)
Passion for customer service
Education and Work Experience:
Bachelor’s Degree in allied health fields such as Nursing, Pharmacy, or Health Science, preferably with clinical trial monitoring experience; or RN with Associates Degree or 3 year Nursing Diploma with 2 years of clinical nursing experience
Minimum of 2-3 years of clinical research monitoring experience
ReSearch Pharmaceutical Services - 20 months ago
ReSearch Pharmaceutical Services (RPS) is a clinical research organization, and a little bit more. The Warburg Pincus-owned company manages...