Clinical Research Associate (CRA)

Job Description:

CRAs have the responsibility to identify, select, initiate and close-out appropriate investigational sites for clinical studies. CRAs will need to ensure that the rights and well-being of human subjects are protected and the reported trial data are accurate, complete, and verifiable from source documents.

Key Responsibilities

·         Act as the main line of communication between Company and the investigators.

·         Build relationships with investigators and site staff.

·         Manage on-site visits and logistics in accordance with the monitoring plan.

·         Verifying that the investigator follows the approved protocol and all GCP procedures.

·         Verifying that source data/documents and other trial records are accurate, complete, and maintained.

·         Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs.

·         Generate visit/contact report in accordance with monitoring plan.

·         Keep manager informed about work progress.

·         Maintain a working knowledge and ensure compliance with applicable GCP and local regulatory requirements.

Key Qualifications

·         Bachelor degree, or local equivalent, in clinical, medicine, or a related science field.

·         Strong computer skills including knowledge of MS-Office products.

·         Regulatory knowledge including GCP.

·         Excellent verbal and written communication skills.

·         Able to take initiative and work independently.

·         Effective time management.

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Organic synthesis scientist

Job Description:

The position will be responsible for the synthesis and identification of innovative drug molecules, to complete the designated R & D goals.

Job Responsibilities:

1, according to the technical director of the arrangements and guidance to complete the target compound route design and synthesis;

2, independent commitment to the target compound synthesis, separation, purification and characterization;

3, proficient in the use of laboratory laboratory equipment, and proficient in laboratory safety requirements;

4. able to solve most of the problems in the experiment;

5. report to the technical supervisor on the progress of the work, feedback the problems, and coordinate the solution;

6, the independent completion of the relevant information collection, literature search and written work;

7. Complete the experimental record clearly and completely, the report is true, detailed and reliable.

8, to complete the other tasks assigned by the supervisor;

job requirements:

1, organic chemistry, materials chemistry, pharmaceutical chemistry and other related professional, undergraduate and above;

2, more than one year of organic synthesis work experience, a strong laboratory safety awareness;

3, able to skillfully complete and optimize multi - step organic synthesis reaction;

4, active thinking, with the ability to analyze and solve problems;

5, hands-on ability, serious and careful, have a good sense of communication and team spirit

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Process R&D scientist

Job Description:

Responsible for drug molecular research, amplification and production.

description of job:

1, independent of the existing process to optimize, improve yield and simplify the operation;

2, can improve the proposed process is feasible and feasible;

3, commissioned by the company CMO raw material kilograms of production;

4, write a project report;

job requirements:

1, organic synthesis or related professional undergraduate and above, have a deeper knowledge of chemical theory;

2, more than three years of work experience, completed more than kilograms of production projects, a wealth of raw materials pilot technology amplification and process transfer experience;

3, a process to enlarge, route optimization, pilot production experience, familiar with the production equipment and process priority;

4, familiar with the GMP system and its certification requirements, GMP workshop production experience;

5, familiar with the synthesis workshop workflow and operation, and commonly used raw material drug production equipment;

6, the work has a strong sense of responsibility, organic synthesis has a strong interest and hobbies, can be hard-working; with motivated and responsible and good team spirit.

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Formulation scientist

Job Description:

Responsible for prescription screening, optimization, amplification and production of pharmaceutical preparations.

description of job:

1, involved in drug preparation prescription screening, process research and optimization, and to achieve the pilot and large production transformation;

2, tracking the development trend of formulation technology research and technology market dynamics, the project preparation design, development and development work;

3, to complete the preparation of new drugs and related reporting materials finishing work.

job requirements:

1, drug preparation and related professional undergraduate and above, more than two years experience in drug preparation research and development;

2, familiar with the pharmaceutical production process, familiar with the solid preparation process of various unit operation and related equipment;

3, familiar with GMP regulations and requirements, familiar with the production process validation and so on;

4, has a wealth of pharmaceutical preparation theory and practical work experience, with a strong literature search, prescription screening and process design capabilities;

5, to understand the registration of drugs related laws and regulations and processes, with a certain amount of data to declare the experience;

6, with a good team spirit, work proactive, strong sense of responsibility.

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Senior medicinal scientist

Job Description:

The position will be responsible for the design, synthesis and identification of innovative drug molecules, and lead the R & D team to complete the specified R & D goals.

Job Responsibilities:

1, independent commitment to the project research and development work;

2, engaged in innovative drug molecular design;

2, to develop project R & D plan to lead the project team to complete the established research tasks, to guide the project team members to complete their daily work;

3, skilled to complete a variety of chemical reactions, open up the synthetic route, optimize the reaction conditions, the preparation of complete, systematic experimental report;

4, responsible for the literature, patent search, the proposed project synthesis route, in time, cost, efficiency and achieved a better balance;

5, according to the company to prepare and send the project report;

6, other tasks arranged by the supervisor.

job requirements:

1, organic chemistry, materials chemistry, pharmaceutical chemistry and other related professional, doctoral degree or more than three years of work experience, a drug research and development background is preferred;

2, master the rich organic chemistry expertise and related practical experience, with excellent synthetic route design capabilities, and skilled completion of multi-step route synthesis;

3, master the laboratory commonly used compounds separation and purification technology and structural identification methods;

4, skilled application of commonly used literature search tool, can independently search the literature and timely and accurate reading translation of foreign literature;

5, with a strong sense of laboratory safety;

6, with a good level of English, can use English for professional writing;

7, hands-on ability, careful and careful, have a good sense of communication and team spirit.

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Clinical Trial Assistant (CTA)

Job Description:

CTAs will provide administrative support to clinical projects under direction of line manager, Clinical Research Associate and/or other designated clinical team members. CTAs could be required to provide general administrative functions.

Key Responsibilities

·         Collection, scanning, copying, archiving and maintenance of clinical study documents.

·         Coordination clinical study events, e.g. the arrangement of investigator meeting and recording of meeting minutes.

·         Support CRA team to complete site monitoring.

Key Qualifications

·         Bachelor degree, or local equivalent, in clinical, medicine, or a related science field.

·         Good in written English as well as local language.

·         Good communications skills.

·         Proven ability to work within a team.

·         Must demonstrate good computer skills. 

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Clinical Project Manager (CPM)

Job Description:

To manage the clinical trials in respiratory and other viral infection indications with specific focus on the technical (medical/scientific) input and operational coordination of clinical studies, with external experts, service providers, internal department and project teams.

Key Responsibilities

        ·         Serve as the primary point of contact for Sponsor.

        ·         Management of all logistical and operational activities from study start-up through closeout, ensuring adherence to regulatory guidelines, company SOPs, study timelines
               and inspection readiness.

        ·         Oversight and management of CRO and third-party vendors.

        ·         Develop, communicate and evaluate trial management plans to include trial team objectives, workflows and timelines.

        ·         Coordinate and collaborate with data managers, statisticians and any other trial team members.

        ·         Coordinate, manage and document all trial team meetings, to include preparation and maintenance of agendas and meeting minutes.

        ·         Develop and/or provide input and review on study related documents such as clinical monitoring plans, data management plans, protocols, informed consents, case report
               forms (CRF), CRF completion guidelines, EDC training guides clinical study reports, statistical analysis plans, site instructions for specimen collection, laboratory manuals,
               investigative site GCP and protocol training materials, investigator newsletters etc.

        ·         Providing oversight and management for filing study records in the Trial Master File (TMF).

        ·         Providing oversight, support and input to collect and maintain appropriate documentation for adverse event safety reporting and collaborating in the submission of safety
               reports to the FDA, IRBs/IECs and other applicable regulatory authorities.

        ·         Development of recruitment strategies to increase patient enrollment.

        ·         Developing tools for the provision, accountability and tracking of clinical trial materials such as Investigational Product (IP) and non-IP materials to investigative sites for
               the duration of the trial and ensuring site accountability records are maintained.

        ·         Overseeing site initiation, interim monitoring and close-out visits as needed to include training materials used during visits.

        ·         Responsible for the financial management of the clinical trial including budget planning and tracking, resource allocation and preparation of quarterly reports.

        ·         Training and coaching of internal CRAs as required.

        ·         Providing support and assistance to sites for audit and inspection readiness.

Key Qualifications

        ·         Doctorate, Masters or Bachelors degree. Major course of study must be science or health related. 

        ·         Four or more years of clinical operations experience for CPM; with increasing levels of responsibility, in the Pharmaceutical, or Biotechnology industry is required.

        ·         Therapeutic experience in respiratory or infection disease (preferred).

        ·         Read, write and speak fluent English; excellent verbal and written communication skills.

        ·         Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research
               and data management methods.

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