About the role
Cliantha is currently seeking a Quality Control Specialist/Report Specialist; who can fulfill its business needs and is looking for better learning and growth opportunities.
About Us
Cliantha Research is a full service Clinical Research Organization (CRO) that provides comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Tobacco Research, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, and Environmental Exposure Chambers (EECs).
With several advanced clinical sites and bio-analytical laboratories in North America and India, Cliantha now has presence in 4 countries along with a strong team of 1000+ professionals. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and others have successfully inspected Cliantha across the globe.
Cliantha Research is headquartered in Ahmedabad and has expanded its domestic presence with 5 regional offices & international presence with offices in USA (Florida & New Jersey), Canada (Mississauga, Winnipeg & Scarborough) & Europe (Portugal).
JOB SUMMARY: Function as an analytical scientist and assure that data and documentation for the assigned project is compiled and checked for accuracy. Ensure that data are prepared in accordance to SOPs and protocol. Any problems or deviations from SOP during the course of the study are brought to the attention of the Head of the department.
BASIC SKILLS AND ABILITIES: Knowledge of Chemistry and basic regulatory guidelines for the conduct of analytical phases of clinical BA/BE and non-clinical studies. Adhere to the requirements of the OECD, FDA, and EMEA Principles of GLP, GCP guidelines, safety standards and SOPs. Skills for proofreading, being able to communicate and resolve compliance related matters. Attention to details.
1) Handles tasks under direction and guidance
2) Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency and completeness
3) Work with QC manager and QC Specialists to ensure study specific QC plans are followed during clinical trials, ensuring QC processes are in alignment with Cliantha Research SOPs and study protocols
4) Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
5) Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required under the guidance of QC manager/QC Specialists
6) As required, follow-up on all QC findings, until a satisfactory resolution has been determined
7) Assure documentation review meets or exceeds designated timeline parameters
8) Maintain a working knowledge of relevant US, Canadian and European GxP regulations as well as ICH regulations
9) Ensuring training file and SOP reading is maintained and up to date
10) Ensure compliance with appropriate Cliantha Research SOP’s, GCP and ICH guidelines
11) Participate in training sessions
12) Participate in training of staff as experience and qualifications permit
13) Work in a safe manner that does not endanger yourself or co-workers
14) Execute other duties as may be required by the QC Manager and other members of Management team as training and experience allow
Qualifications:
· High School diploma or equivalent. Prefer a Bachelor degree, with a minimum of two years of college, university, or technical school education in life science or relevant scientific discipline.
· Ability to use computers and software associated with their job function (e.g. Microsoft Excel, Word and Outlook)
· 0-2 years of relevant experience in a clinical research setting
· Strong eye for detail and ability to spot inconsistencies a must
· Good conflict management skills
· Displays a basic ability to identify, anticipate and define issues in a timely manner and to understand the potential impact of issues. Sufficient awareness to notify a supervisor when the problem is beyond the individual’s ability to resolve, or as otherwise appropriate.
· Displays some analytical and problem solving skills and the ability to present solutions
· Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
· Excellent interpersonal skills
· Strong written and verbal communication skills
· Strong analytical and problem solving skills
· Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
· Excellent interpersonal skills
· Strong written and verbal communication skills
Job Types: Part-time, Permanent
Work Location: In person
About Cliantha Research Limited
Cliantha Research, a full-service Clinical Research Organization (CRO), is a leading provider of Clinical research services, based in Ahmedabad, India. Cliantha’s mission is Science with Integrity. Cliantha has fifteen years of impeccable regulatory history with USFDA, WHO, MHRA, Health Canada, AGES, AEMPS, MCC, MOH, ANSM, MOPH, ANVISA, CAP, and NABL.
About the role
Cliantha is currently seeking a Quality Control Specialist/Report Specialist; who can fulfill its business needs and is looking for better learning and growth opportunities.
About Us
Cliantha Research is a full service Clinical Research Organization (CRO) that provides comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Tobacco Research, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, and Environmental Exposure Chambers (EECs).
With several advanced clinical sites and bio-analytical laboratories in North America and India, Cliantha now has presence in 4 countries along with a strong team of 1000+ professionals. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and others have successfully inspected Cliantha across the globe.
Cliantha Research is headquartered in Ahmedabad and has expanded its domestic presence with 5 regional offices & international presence with offices in USA (Florida & New Jersey), Canada (Mississauga, Winnipeg & Scarborough) & Europe (Portugal).
JOB SUMMARY: Function as an analytical scientist and assure that data and documentation for the assigned project is compiled and checked for accuracy. Ensure that data are prepared in accordance to SOPs and protocol. Any problems or deviations from SOP during the course of the study are brought to the attention of the Head of the department.
BASIC SKILLS AND ABILITIES: Knowledge of Chemistry and basic regulatory guidelines for the conduct of analytical phases of clinical BA/BE and non-clinical studies. Adhere to the requirements of the OECD, FDA, and EMEA Principles of GLP, GCP guidelines, safety standards and SOPs. Skills for proofreading, being able to communicate and resolve compliance related matters. Attention to details.
1) Handles tasks under direction and guidance
2) Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency and completeness
3) Work with QC manager and QC Specialists to ensure study specific QC plans are followed during clinical trials, ensuring QC processes are in alignment with Cliantha Research SOPs and study protocols
4) Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
5) Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required under the guidance of QC manager/QC Specialists
6) As required, follow-up on all QC findings, until a satisfactory resolution has been determined
7) Assure documentation review meets or exceeds designated timeline parameters
8) Maintain a working knowledge of relevant US, Canadian and European GxP regulations as well as ICH regulations
9) Ensuring training file and SOP reading is maintained and up to date
10) Ensure compliance with appropriate Cliantha Research SOP’s, GCP and ICH guidelines
11) Participate in training sessions
12) Participate in training of staff as experience and qualifications permit
13) Work in a safe manner that does not endanger yourself or co-workers
14) Execute other duties as may be required by the QC Manager and other members of Management team as training and experience allow
Qualifications:
· High School diploma or equivalent. Prefer a Bachelor degree, with a minimum of two years of college, university, or technical school education in life science or relevant scientific discipline.
· Ability to use computers and software associated with their job function (e.g. Microsoft Excel, Word and Outlook)
· 0-2 years of relevant experience in a clinical research setting
· Strong eye for detail and ability to spot inconsistencies a must
· Good conflict management skills
· Displays a basic ability to identify, anticipate and define issues in a timely manner and to understand the potential impact of issues. Sufficient awareness to notify a supervisor when the problem is beyond the individual’s ability to resolve, or as otherwise appropriate.
· Displays some analytical and problem solving skills and the ability to present solutions
· Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
· Excellent interpersonal skills
· Strong written and verbal communication skills
· Strong analytical and problem solving skills
· Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
· Excellent interpersonal skills
· Strong written and verbal communication skills
Job Types: Part-time, Permanent
Work Location: In person
About Cliantha Research Limited
Cliantha Research, a full-service Clinical Research Organization (CRO), is a leading provider of Clinical research services, based in Ahmedabad, India. Cliantha’s mission is Science with Integrity. Cliantha has fifteen years of impeccable regulatory history with USFDA, WHO, MHRA, Health Canada, AGES, AEMPS, MCC, MOH, ANSM, MOPH, ANVISA, CAP, and NABL.