Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide.  We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions.  We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology.  If you’d like to join a company where you can make a difference, please consider the Celgene family.

Sr. CRA, Regional Clinical Operations – Miami FL

Prerequisites:

Completed BS / BA / RN degree required; scientific degree concentrations preferred.  Must have at least 8 years professional working experience in the pharmaceutical / medical industry, including at least 4 years of direct site monitoring experience.

Summary/Scope:

Monitor assigned investigative sites to ensure subject safety and timely high quality data in compliance with regulations.

Responsibilities will include, but are not limited to the following:

1.       Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; conduct Pre-study Visits at Investigative Sites; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review investigator study files and reconcile versus trial master files; perform investigational product accountability; conduct Close-out Visits at Investigative Sites.

2.       Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; ensure issues of data quality are escalated and resolved with study team and CQA.

3.       Subject Safety - Perform safety reviews/SAE reconciliations; monitor the informed consent process; eensure investigative sites’ adherence to GCP, ICH guidelines, and local regulations.

4.       Train and Assist Investigative Sites - Attend Investigator Meetings; train investigative site personnel in GCP and ensure sites are conducting Celgene clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as the liaison between Celgene and assigned sites; build relationships with site staff at assigned sites.

5.       Communication - Identify site issues, ensure proper escalation, if necessary, and ensure resolution; create trip reports, confirmation/follow-up correspondence and telephone contacts for assigned sites; respond to audit findings; adhere to proper lines of communication within Celgene; attend and participate in study team meetings; keep information in the CTMS current; maintain calendar.

6.       Development - Maintain up-to-date medical and clinical knowledge for assigned therapeutic areas; mentor / coach new CRAs; maintain annual training records.

7.       Corporate Goals - Identify/evaluate potential investigators for future Celgene studies; build effective and positive relationships with Principal Investigators; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; schedule travel following Celgene’s travel policy, and submit expense reports in an accurate and timely manner.

8.       Regulatory Documentation - Prepare ethics submissions and local regulatory documents at the country level, as needed; maintain local document files at a country level, as needed; review translations for ICD and other study documents, as needed; oversee to assure SOPs are followed in obtaining translations on necessary study documents.

9.       Monitoring Lead (As assigned) - Serve on study team as monitoring representative; review RFPs regarding monitoring specifications; develop the study monitoring plan and subsequent revisions; review, track and acknowledge monitoring visit reports; manage and track monitoring site visits to ensure quality monitoring; ensure adequate monitoring resources; ensure monitors are trained properly in the study requirements; track and report critical issues to study team; participate in CRF and protocol review process; attend, participate and present at Investigator Meetings; perform field assessments of Celgene and CRO FMs, as required; develop study-specific tools for Investigative sites and Field Monitors; conduct FM meetings; oversee CRO monitoring, as required.

Skills/Knowledge Required:

·          Significant medical and scientific knowledge

·          Knowledge of investigational products under study

·          Ability to comprehend protocols and supportive information

·          Knowledge of Clinical Development Process

·          Knowledge of regulatory environment and guidelines (ICH, GCP and CFR)

·          Excellent written and oral communication skills, including presentations

·          Excellent relationship-building skills

·          Ability to work in a cross-functional team environment

·          Ability to work independently

·          Working knowledge of SOPs relevant to position

·          Demonstrated problem-solving skills

·          Ability to resolve routine issues effectively and independently

·          Organizational and time management skills

·          Knowledge of software (EDC, CTMS, MS Office, etc.)

·          Ability to travel extensively within North America including overnight stays

·          Ability to drive an automobile and have a valid driver’s license

Key (PDI) Competencies:

·          Works Efficiently

·          Prepares Written Communications

·          Builds Relationships

·          Fosters Teamwork

·          Shows Work Commitment

·          Uses Scientific/Technical/ Functional Expertise

·          Commitment to Quality

·          Acts with Integrity

·          Demonstrates Adaptability

·          Develops Oneself

·          Uses Sound Judgment

Apply at www.celgene.com/careers/pharmaceutical-us-job-openings.aspx or visit our website to view all of our open positions at www.celgene.com .

Celgene Corporation is an equal opportunity employer.