The Regional Clinical Research Associate completes project activities associated with monitoring functions of Phase I-IV clinical research studies. Perform 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
- Must have 4+ years experience.
- Must be able to handle multiple protocols and Therapeutic Areas
- Proficient with EDC(Inform) CTMS(Impact)
- Flexible for travel
- Has completed all site visits from pre-study to close outs.
ReSearch Pharmaceutical Services - 16 months ago
ReSearch Pharmaceutical Services (RPS) is a clinical research organization, and a little bit more. The Warburg Pincus-owned company manages...