Role Description

Scientific > Clinical Research Associate

Salary National Average

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55450.0000 91510.0000 106010.0000

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Short Description:

Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe to allow on the market.

Duties / Responsibilities:

  • Creating and writing trial protocols, and presenting these to steering committee.
  • Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial.
  • Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.
  • Liaise with ethics committee regarding rights, safety and well-being of trial subjects.
  • Ordering, tracking, and managing IP and trial materials.
  • Overseeing and documenting IP dispensing, inventory and reconciliation.
  • Protecting subjects’ confidentiality, updating their information, and verifying IP has been dispensed and administered according to protocol.
  • Conducting regular site visits, coordinating project meetings and writing visit reports.
  • Implementing action plans for sites not meeting expectations.
  • Liaising with regulatory authorities.
  • Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
  • Other tasks and responsibilities as needed.

Skills / Requirements / Qualifications

  • Excellent communication, both written and verbal, and interpersonal skills
  • The ability to build effective relationships with trial center staff and colleagues
  • The ability to motivate others
  • Strong customer focus
  • An excellent grasp of numeracy and a keen eye for detail
  • Presentation skills
  • The ability to multitask and think on your feet
  • Project management skills
  • A flexible and adaptable approach to work
  • Organizational, IT and administrative skills - the job involves a lot of documenting and recording information through computerized processes, such as clinical trial management systems and electronic data capture
  • An understanding of the importance of good clinical practice (GCP), which is a legal requirement for all CRAs.

Job Zones

  • Title:  Job Zone Four: Considerable Preparation Needed
  • Education:  Most of these occupations require a four-year bachelor's degree, but some do not.
  • Related Experience:   Most of these occupations require a four-year bachelor's degree, but some do not.
  • Job Training:  Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
  • Job Zone Examples:  Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, chemists, art directors, and cost estimators.
  • SVP Range: (7.0 to < 8.0)

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