Company: Novella Clinical Resourcing
Location: Stevenage, UK
Reference: NC-1625191 Clin Saf
Closing Date: 24 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: Include bonus, pension, life and health insurance
Clinical Safety Specialist required by Novella Clinical, a Quintiles company. Primary function is to process and report incoming safety events. Full time, permanent role, office based in Stevenage. At least 12 months prior experience in Clinical Trials Safety.
Novella Clinical, a Quintiles company, has a vacancy for a Clinical Safety Specialist to work within their EU Safety Reporting group. The primary responsibilities of this role include processing and reporting of incoming safety events and related data.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
· Performs safety case processing tasks including, but not limited to:
Ø Intake and triage tasks as performed by Clinical Safety Associate and/or Senior Clinical Safety Associate
Ø Reviewing incoming safety information for completeness and accuracy
Ø Tracking and data entry
Ø Writing clinical narratives
Ø Generating queries
Ø Contacting sites for missing and/or unclear information
Ø QC of cases
Ø Generating regulatory reports
Ø Generating metrics
· May serve as Safety Management lead on small to moderate sized studies that are simple to moderate in complexity and scope of work with guidance from senior staff. Responsibilities include, but are not limited to:
Ø All aspects of Safety Management start-up process including writing Safety Management Plan, developing SAE form, etc.
Ø Attendance at team and client meetings
Ø Investigator's meeting attendance
Ø Training of staff on safety processes
Ø Compliance with budget, including estimating monthly budget projections
· Ensures compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager.
· May assist with bid defenses or other presentations.
· May mentor and/or train new Safety Management staff.
Performs other related duties as assigned or requested department Management
KNOWLEDGE, SKILLS AND ABILITIES:
· In depth knowledge of clinical research process and medical terminology.
· Able to identify, analyze and problem solve moderately complex issues and trends with guidance and support from senior staff.
· Excellent written and verbal communication skills. Able to express complex ideas.
· Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Safety Management department activities.
· Able to develop knowledge of the disease under study. Able to discuss simpler aspects of the disease process with site personnel and colleagues.
· Able to develop knowledge of protocol, regulatory requirements and company SOPs. Familiar with matrix team structure and phases of research. Able to identify and document regulatory non-compliance and any issues involving subject safety.
· Good organizational and interpersonal skills.
· Ability to reason independently to assess and recommend specific solutions in a clinical setting.
· Attention to detail. Able to identify and resolve discrepancies on SAE reports and case report forms.
· Understands electronic data capture including basic data processing functions.
· Understands current ICH/ GCP guidelines applicable to the conduct of clinical research.
Candidates for this role should have at least 12 months experience in a similar position.
This is a full time, permanent position which is office based in Stevenage. Some home working may be permissable after 6 months.
Key words: clinical safety, safety reporting, pharmacovigilance, PVG, regulatory safety reporting.
Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
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