Medical Surveillance - Trainee-1604015
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
Description
PURPOSE
Support Medical Surveillance Specialist to provide a wide range of medical surveillance support including monitoring of clinical laboratory data for subjects in clinical studies and composing medical narratives and interfacing with investigator sites.
RESPONSIBILITIES
- Supports the Medical Surveillance Specialist in monitoring, evaluating and analyzing laboratory results on a daily basis, from sponsor designated central laboratory using sponsor-designated data management system.
- Support the monitoring of Laboratory safety parameters for each patient at every site throughout clinical drug trial.
- Supports in conducting preliminary review of laboratory results relative to established protocol-specific reference range guidelines.
- Get trained on the process to follow established procedure for comparing current results with prior laboratory values to identify trends or potentially clinically significant increases/decreases, identify instances in which additional guidance is sought with Sponsor/Quintiles physicians for medical evaluation of case, as needed.
- Get trained on review and evaluation of retest results, initiating contact with investigative site, if appropriate.
- Composes telephone reports documenting site contact to include all clinically relevant information. Distribute according to scheme designated at project inception.
- Attends project team meetings, as needed.
- Performs other related duties as assigned.REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Basic Knowledge of Medical /Scientific Terminology
- Excellent organizational, communication and computer skills required.
- Ability to exercise excellent attention to detail.
- Ability to act independently and with initiative required to resolving problems.
- Strong analytical skills
- Strong Excel Skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Master’s degree in Life science / Pharmacy or educational equivalent (BDS, BHMS, BAMS) and up to 6 months of relevant experience in Clinical Research; or equivalent combination of education, training and experience .
PHYSICAL REQUIREMENTS
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
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