Drug Safety/Medical Information Specialist jobs in Indianapolis, IN

This position is part of the Indiana Department of Health Laboratory, Advanced Molecular Detection Division

Purpose of Position/Summary:

Incumbent is responsible for coordinating and performing the full range of molecular biological examinations and analyses, recording, interpreting, and result reporting of tests on specimens which may include human body fluids, tissues (human and animal), isolates from clinical specimens, and environmental samples to the submitting physician, clinic, hospital, or public health agency. Incumbent is also responsible for the development, validation, and implementation of new molecular tests, preparation of validation documents and SOPs, and troubleshooting of the existing molecular tests. Special emphasis for this position will be around genomic sequencing, maintenance of instrumentation for sequencing, and troubleshooting sequencing assays.

Essential Duties/Responsibilities:

Incumbent will have in-depth knowledge and ability in the areas of molecular biology and is able to perform laboratory associated assays or the ability to learn these techniques upon successful completion of proficiency testing. Representative duties include:

• Extraction of nucleic acids from specimens, isolates, and samples via a variety of manual and automated methods;

•Utilize molecular techniques such as, but not limited to, PCR, MALDI-TOF, and NGS;

•Participate in the evaluation, development, validation, and implementation of new testing methods used in clinical/reference laboratory work, as well as, preparation of validation documents and SOPs;

•Provide technical oversight of the daily performance of high complexity testing; strictly following the laboratory's procedures for specimen handling and processing, test analyses, reporting, and maintaining records of test results;

• Maintain laboratory record system of submitted samples and specimens and their possible referral;

• Evaluate, interpret, validate laboratory results, and report findings;

• Conduct quality control checks on laboratory methods, materials, and equipment;

• Document all quality control activities, instrument calibrations, and maintenance performed;

• Participate in evaluation of new products used in clinical/reference laboratory work;

• Perform all related work as required;

•Testing personnel responsibilities (42 CFR 493.1495 Standard):

The testing personnel are responsible for specimen processing, test performance and for reporting test results.

(a) Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual’s education, training or experience, and technical abilities.

(b) Each individual performing high complexity testing must—

(1) Follow the laboratory’s procedures for specimen handling and

processing, test analyses, reporting and maintaining records of patient

test results;

(2) Maintain records that demonstrate that proficiency testing samples are

tested in the same manner as patient specimens;

(3) Adhere to the laboratory’s quality control policies, document all quality

control activities, instrument and procedural calibrations and

maintenance performed;

(4) Follow the laboratory’s established policies and procedures whenever

test systems are not within the laboratory’s established acceptable levels

of performance;

(5) Be capable of identifying problems that may adversely affect test

performance or reporting of test results and either must correct the

problems or immediately notify the general supervisor, technical

supervisor, clinical consultant, or director;

(6) Document all corrective actions taken when test systems deviate from

the laboratory’s established performance specifications; and

(7) Except as specified in paragraph (c) of this section, if qualified under §

493.1489(b)(5), perform high complexity testing only under the onsite,

direct supervision of a general supervisor qualified under § 493.1461.

(c) Exception. For individuals qualified under § 493.1489(b)(5), who were performing

high complexity testing on or before January 19, 1993, the requirements of

paragraph (b)(7) of this section are not effective, provided that all high complexity

testing performed by the individual in the absence of a general supervisor is

reviewed within 24 hours by a general supervisor qualified under § 493.1461

Job Requirements:

• Extensive knowledge of the principles, theories and practices of molecular biology, and related sub- specialties;

• Experience with Next Generation Sequencing platforms, technologies, and procedures.

• Specialized knowledge of current scientific methods and testing procedures and the ability to apply them when seeking solutions to public health laboratory problems;

• Specialized knowledge of and ability to use a full range of standard technical equipment, complex scientific apparatus, and automated techniques of analysis;

• Extensive knowledge of laboratory safety practices and principles;

• Aware of state and federal laws, rules, regulations, and policies concerning the program area (i.e. CLIA);

• Ability to meet requirements for personnel certification as a technologist pursuant to the Clinical Laboratory Improvement Act (CLIA)

• Ability to effectively communicate technical information both verbally and in writing and maintain productive working relationships;

• Ability to satisfactorily participate in proficiency testing programs and recognize QA problems;

• Ability to compile, analyze, evaluate, and prepare laboratory reports.

Difficulty of Work:

Incumbent is engaged in scientific analyses that demand accuracy and demonstrated proficiency in applying laboratory analytical skills to select pertinent guidelines and formulated plans for problem solving. Projects involve many complex variables of great intricacy and the microbiologist is often called upon to analyze and identify unusual specimens/samples. Work requires considerable use of analytical judgement and technical knowledge in order to draw accurate, logical conclusions. Incumbent will also be required to develop and research new testing procedures.

Responsibility:

Incumbent works independently as an expert in the Biothreat laboratory. Technical and/or detailed instruction is provided only upon request when a procedural change and/or special project necessitates it. Incumbent maintains established safety practices when working with materials that have a chemical hazard or biohazard potential. Reports are reviewed for general technical accuracy; however, tasks are performed independently. Errors in work could adversely affect the health, safety and well being of the incumbent or coworkers.

Personal Work Relationships:

Incumbent works with supervisor and with other Department of Health staff such as Laboratory Safety Officer and/or external entities (e.g. local health departments, etc.) to devise and implement work procedures and information dissemination. Individual will have contact with employees and the public as a laboratory expert and in the explanation of laboratory procedures and recommendations when appropriate.

Physical Effort:

The incumbent will be performing tests on potentially dangerous samples (e.g. anthrax). Because of this, safety standards are of primary importance. This position will be required to use all appropriate personal protective equipment in the designated laboratory area.

Working Conditions:

The equipment can be cumbersome and awkward; the laboratory space can experience a dramatic increase in temperature. The incumbent will be required to work in these conditions and maintain a clear thought process during the testing.

Job Type: Contract

Pay: $31.14 per hour

Expected hours: 37.5 per week

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• NGS using an Illumina Instrument or a PacBIO instrument.: 2 years (Required)
• scientific methods and testing procedures: 2 years (Required)
• compile, analyze, evaluate, and prepare laboratory reports: 2 years (Required)

Ability to Commute:

• Indianapolis, IN 46202 (Required)

Work Location: In person