Clinical Safety Specialist (Contract, Office-Based) - Novella Clinical

Novella Clinical seeking Contract Clinical Safety Specialist:

Delivers Safety Management Department servicesaccording to ICH-GCP guidelines, regulatory requirements and Novella SOPs and/orproject specific procedures.

Primary responsibilities include processing andreporting of incoming safety events and related data.

May serve as Safety Management Lead on small tomoderate sized studies that are simple to moderate in complexity and scope ofwork with support from senior staff.


  • Performs safety case processing tasks including,but not limited to:

Ø Intake and triage tasks as performed by Clinical Safety Associate and/orSenior 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 Reconciliation

Ø Generating metrics

  • May serve as Safety Management lead on small tomoderate sized studies that are simple to moderate in complexity and scope ofwork with guidance from senior staff. Responsibilities include, but are notlimited to:

Ø All aspects of Safety Management start-up process including writingSafety Management Plan, developing SAE form, etc.

Ø Attendance at team and client meetings

Ø Investigator’s meeting attendance

Ø Presentations

Ø Training of staff on safety processes

Ø Compliance with budget, including estimating monthly budget projections

  • Ensures compliance with client budget andproactively escalates potential scope changes or noncompliance with cost ortime allocation to department Manager.
  • May assist with bid defenses or other presentations.
  • May mentor and/or train new Safety Managementstaff.
  • Performs other related duties as assigned orrequested department Management


  • In depth knowledge of clinical research process andmedical terminology.
  • Able to identify, analyze and problem solvemoderately complex issues and trends with guidance and support from seniorstaff.
  • Excellent written and verbal communication skills.Able to express complex ideas.
  • Positive attitude and ability to interact with alllevels of staff to successfully coordinate and execute Safety Managementdepartment activities.
  • Able to develop knowledge of the disease understudy. Able to discuss simpler aspects of the disease process with sitepersonnel and colleagues.
  • Able to develop knowledge of protocol, regulatoryrequirements and company SOPs. Familiar with matrix team structure and phasesof research. Able to identify and document regulatory non-compliance and anyissues involving subject safety.
  • Good organizational and interpersonal skills.
  • Ability to reason independently to assess andrecommend specific solutions in a clinical setting.
  • Attention to detail. Able to identify and resolvediscrepancies on SAE reports and case report forms.
  • Understands electronic data capture including basicdata processing functions.
  • Understands current ICH/ GCP guidelines applicableto the conduct of clinical research.
  • Demonstrates professionalism and presents apositive image of the company.
  • Prioritizes time effectively based on projectneeds. Consistently meets deadlines. Seeks management input with anydifficulties in establishing priorities.
  • Identifies personal career development goals andopportunities related to current job. Solicits and applies performancefeedback.
  • Demonstrates commitment, dedication, cooperation,positive behavior, adaptability and flexibility with changes inresponsibilities and duties.
  • Demonstrates honesty and integrity in dealing withothers. Works effectively with different types of people. Accepts constructivefeedback without becoming defensive.
  • Seeks input from others when faced with a difficultsituation. Makes sound decisions within the scope of responsibility. Focuses onresolving problems rather than placing blame.
  • Establishes and maintains effective relationships withcustomers (internal and external) and gains their trust and respect. Providescustomers with complete and accurate information. Maintains a high energy levelwhen interacting with customers. Acts with the customer in mind.
  • Able to work independently and identify issues andsolutions proactively with guidance and mentorship from senior level staffand/or Safety Management Management.
  • Bachelor’s Degree in one of the life sciences orclinical research and/or a licensed healthcare professional required.
  • Minimum of 1 year of experience in clinical trialsafety.
  • Equivalent combination of relevant education andexperience.
  • Computer literacy and experience working withMicrosoft Office (Word, Excel) required
  • Knowledge of electronic data capture preferred.
  • Excellent verbal and written communication skillsrequired.
  • Excellent interpersonal and organizational skillsrequired.
  • Ability to work independently, prioritizeeffectively and work in a matrix team environment required.
  • Ability and willingness to travel domestically andinternationally as required; ability to rent automobile.

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