公司介紹：novo nordisk

諾和諾德公司（novo nordisk）是一家致力于人類(lèi)健康、以先進(jìn)的生物技術(shù)造?；颊?、醫(yī)生和社會(huì)的世界領(lǐng)先生物制藥公司。諾和諾德公司在行業(yè)內(nèi)擁有最為廣泛的糖尿病治療產(chǎn)品，其中包括最先進(jìn)的胰島素給藥系統(tǒng)產(chǎn)品，80多年來(lái)一直是世界糖尿病研究和藥物開(kāi)發(fā)領(lǐng)域的主導(dǎo)。此外，諾和諾德還在止血管理、生長(zhǎng)保健激素以及激素替代療法等多方面居世界領(lǐng)先地位。

Key responsibilities ：

1.The CRA is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company and contributes to making Novo Nordisk the preferred partner.

2.The CRA is responsible for taking leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, Novo Nordisk procedures and protocol requirements to ensure data quality and study subject protection.

3.The CRA is responsible for managing the site to meet patient recruitment rate and target.

4.The CRA thereby delivers results that have direct impact on the successful completion of the clinical programme.

5.The CRA coordinates with LTM and RTM and communicates to them progress and critical issues that may impair trial progress.

 

Main job tasks :

（1）Conducts trials in accordance with protocol requirement, GCP, ICH guidelines, local regulations and NN SOPs:

Clinical Research Associate (CRA) is the primary point of contact between site staff and Novo Nordisk. Maintain the good relationship with investigative sites. In this role the CRA acts as ambassador for the company.

Responsible for taking leadership of site management activities regarding the implementation, monitoring, and summarization of clinical trials to ensure adherence to trial protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations and NN SOPs.Ensure data quality and study subject protection. Develop and maintain collaborative working relationships with clinical investigative sites in China.

The CRA is as such responsible for recruitment at site level. The CRA thereby delivers results that have a direct impact on the successful completion of the clinical programme.

1.Efficient and accurate site feasibility visits including analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies.

2.Proactive use of EDC for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team

3.Performs and facilitates study start-up activities including site initiation and training, providing site level information for country recruitment plan, etc. and evaluate site recruitment activities. Ensure site understands protocol requirements, study conduct, and adherence to ICH-GCP guidelines, local regulatory requirements and NN core and local SOPs.

4.Maintains close contact with clinical trial site personnel and assists site with set-up, coordination and problem solving during the conduct of a clinical trial.

5.Performing monitoring visits according to plan, document actions and follow up on action plans. Writes and submits timely and accurate monitoring visit reports, site contact reports and study correspondence/documentation (including documentation, approval and follow-up of protocol deviations) as per monitoring requirement.

6.Manage trial product requirements, incl. temperature deviations and training of site staff. Performs site level drug accountability, reconciliation and destruction activities. Verify storage and shipment requirements are within study standards. Ensure timely completion of paperwork for shipment and storage deviations.

7.Train and guide site staff in the protocol and trial procedures to minimise protocol deviations (PDs)

8.Train site staff in safety information handling and systems.

9.Know and meet all local and company requirement with respect to safety reporting

10.Collaborate with Data Management/logistics in resolving queries

11.Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan

12.Ensures proper return and destruction of all investigational study drugs, including return and disposition of study related supplies and equipment.

13.Verify storage and shipment of biological samples and other protocol specific diagnostic requirements.

14.Motivate and build strong relations with site personnel to ensure NN is their preferred clinical research partner.

15.Collection and management of essential documents

16.Participation at Investigators Meetings to ensure relations with sites as well as active presentation as applicable

17.Conduct study close-out activities

18.Ensure collaboration with and deliverables from vendors locally, if applicable

Ensure investigator understands requirements for archiving. Support  the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF).

 

（2）Additional responsibilities:

1.Timeliness in deliveries through process planning and goal setting

2.Identify potential risks and proactively take action to prevent or mitigate

3.Knowledge of IW/VRS functions incl. training of site staff

4.Therapeutic knowledge as applicable according to the demonstrated understanding of diseases and treatments

5.Monitor and communicate internally any  site observations critical to business results

6.Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements

7.Knowledge of filing and archiving trial documentation in the Sponsor Trial Master File (STMF)

8.Maintaining up to date knowledge of diabetes treatment, company products, and clinical trial conduction.

9.Support audit and inspections at sites and affiliate as applicable

10.Proficient use of NN systems (e.g. IMPACT, CATS, Investigator Portals)

11.Ensure that mandatory entries for all business systems are in compliance with set department and trial goals (i.e. IMPACT, CATS, EDC, IWRS, etc.).

12.Ensure to list compliance/quality related tasks/responsibilities and specific, assigned acts of authority (QMS requirements) – also include information on independence and decision-making authority.

Education :

1.Bachelor’s degree or above of Medical Science, e.g. medical, pharmacy, nursing, etc.

2.Adequate English verbal and written skills.

 

Experience :

1.Requires a minimum of one year clinical trial experience within pharmaceuticals industry or CRO; preferably in clinical monitoring. Other experience may also be relevant, e.g. as study staff at a clinical research site.

2.Knowledge of Good Clinical Practice (GCPs), ICH Guidelines, and local regulations, research process and scientific knowledge as relates to clinical trial conduct.

3.Willingness to travel.

 

Personal skills :

1.Ability to build and maintain relationships with sites.

2.Flexible is very important due to the large number of minor and major tasks coming from different customers.

3.Excellent communication and negotiation skills.

4.High focus on delivery and quality. 

5. Efficient.

6.IT proficiency.

7.Ability to manage multiple priorities.

8.Team oriented personality with high degree of flexibility.

9. Initiative and continuous improvement.

10.Teamwork and collaboration.

11.Ability and willingness to adjust quickly to new situations in a continuously developing environment.

12.Act as an ambassador for NN values.

13.High degree of trustworthiness.

14.Adequate English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports.

15.Proven decision making and problem solving capabilities.


職位聯(lián)系人

Charles Xu

電話:021-64459975-8037

郵箱:charles.xu@isaac-kenneth.com