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 & Scarborough).
JOB SUMMARY:
Lab Coordinator: Function as an analytical scientist to ensure the integrity of samples/specimens is maintained during the samples/specimens handling. The Lab Coordinator is responsible for the receipt, storage, transfer, and disposal of study specimens/samples received at the facility.
Archivist: Function as an analytical scientist and assure that data and documentation for the assigned project is compiled and checked for accuracy prior to archiving. Ensure that archived materials prepared in accordance to SOPs, protocols and study plans. Demonstrate ability to perform label, sort, archive the study raw data, other relevant data, report materials , prepare archival database and archival logs. 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 all basic wet chemistry, instrumentation such as centrifuge, vortexer, pH meter, evaporator, sonicator, analytical balance, fume hood, freezer, refrigerator, water bath, maintaining records of column, volumetric flask and other lab related activities etc. Adhere to the requirements of the FDA 21 CFR PART 58, and OECD Principles of GLP, GCP guidelines, safety standards and SOPs. Demonstrate ability to pipette accurately and ability of handling biological samples of clinical and non-clinical studies and blank matrices, solvents, reagents as well as working/reference standards. Attention to details.
MINIMUM EDUCATION TRAINING AND EXPERIENCE REQUIRED: A minimum of B.Sc. or equivalent education unless demonstrated competence through work experience.
SUPERVISED BY: President & Test Site Management/ Head of Bioanalytical Operations
SUPERVISES: Not Applicable
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of tasks to which employee may be assigned.
Lab Coordinator Activities:
- Logs and tracks the receipt and shipment of all samples/specimens in and out of the laboratory fridges and freezers.
- Sample/specimen receipt, sorting, storage, transfer, shipment or disposal as per in-house procedures, study plan or protocol.
- Label the samples as per the study protocols or in-house procedures.
- Maintain detailed documentation, including laboratory notebooks, for clinical and non-clinical GLP studies.
- Receive blank matrix, reference/test article and its storage.
- Maintenance of temperature chart records, sample shipping.
- Ensure that laboratory equipment is calibrated and routine cleaning performed according to SOPs (e.g. Pipettes).
- Issuance and receipt of working/reference standards.
- Maintain laboratory equipment.
- Coordinate with laboratory personnel for day to day laboratory activities.
- Remain accountable and responsible for IVRT/IVPT investigational products receipt, storage, dispensing, reconciliation and disposal.
- Ensure that IVRT/IVPT investigational product in correct dosage and quantity is dispensed/handled as per the study protocol, randomization and blinding procedure.
- Ensure adequate quantities of IPs (for study analysis as well as retention purpose if applicable) are available. Also, ensure quantity requirement for retention purpose as applicable regulatory requirements/ as instructed by Sponsor.
- Assure labelling as well as accountability of investigational product dispensed and proper documentation is followed.
- Ensure the randomization code shall be sealed and kept in a secure location with controlled access.
Archiving Activities:
- Adhere to the FDA 21 CFR PART 58, OECD Principles of GLP, GCP guidelines, SOPs and other applicable regulatory guidelines.
- To maintain Archive facility, study related documents and databases for the assigned projects.
- Ensure quality and integrity of data being archived.
- Ensure the completeness of documentation pertaining to a study being archived.
- Compile projects for archiving including reconciliation of forms after completion of study.
- Receive, retain and archive all raw data, documents and reports in orderly fashion and in a manner that minimizes deterioration.
- Neatly bind and place all the study material in archiving boxes in orderly manner.
- To prepare index of material retained in the archiving facility according to study name, data of study, identity of sponsor and record in archiving log as well as enter in archiving database.
- Issue the study material according to requirement, retrieve & check/review the documents before the study material is re-archived.
- Responsible for compilation project list which is received from user department and provide the softcopy archival request to IT department.
- Routine replacement of backup tapes.
- Maintain project wise archive CD/DVD.
- Responsible for shipment of records to the sponsor and destruction of records according to SOP.
- Responsible for communication with sponsor related to archival, destruction & shipment of raw data & report.
Administrative Duties:
- Conforms to training schedule for own position and maintains awareness of SOP contents, safety precautions and according to company requirements.
- General Laboratory work (ordering supplies, creating purchasing orders and glassware washing).
General Lab Duties:
- Prepares required reagents and solvents (as required).
- Under direction of the Laboratory Management, perform other laboratory related duties.
Any Additional responsibility given by Head of the Department / Management
Cliantha Research is committed to creating and maintaining a diverse, inclusive, and accessible environment for all its employees and clients. We value diversity at workplace and believe in fostering a spirit of excellence brought in by all our employees and clients. If you require accommodation before, during, or after the interview/recruitment process do not hesitate to let us know when we contact you and we will work with you and do our level best to meet your needs.
Pay: $40,000.00-$45,000.00 per year
Benefits:
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
Work Location: In person
