上海招聘

Essential Function

The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.

Key Accountabilities

• Assume the ability to meet the requirements of a CRA with a high degree of proficiency and autonomy.
• Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects.
• Train team members on selected tasks.
• Keep Manager informed about work progress and any issues to avoid surprised. Requires some interaction / supervision by Manager or assigned mentor.
• Build relationships with client, investigators, and site staff.
• Participate in Investigator and other external or internal meetings as required.
• Arrange on-site visits and logistics (e.g. travel arrangements).
• Perform on-site visits in accordance with the monitoring plan.
• Conduct on-site study-specific training (if applicable).
• Perform site facilities inspection.
• Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations.
• Monitor and maintain ICH-GCP compliance.

• Responsible for the completeness and quality of the on-site files.
• Respond to site issue alerted from Study Team (i.e. non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction).
• Collect Statutory Regulatory Package documents during QV and other visits as needed.
• Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit.
• Update all relevant tracking systems on an ongoing basis.
• Collaborate with Study Team on site issues/actions.
• Generate visit/contact report in accordance with monitoring plan.
• Code and scan Central File documents where applicable.
• Ship relevant wet-ink signature documents to the Assistant or back to the site.
• Escalate any issues that require immediate action to the Study Team.
• Attend audits / Regulatory Inspection if requested.
• Maintain a working knowledge of, and ensure compliance with, applicable ICH-GCP Guidelines, local Regulatory requirements and the company SOPs and study-specific procedures.
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims).

Skills

• Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word.
• Strong regulatory knowledge including GCP.
• Excellent interpersonal, verbal and written communication skills.
• Sound problem solving skills.
• Ability to successfully work in a “virtual” team environment.
• Sound presentation skills.
• Consultative skills.
• Client focused approach to work with the ability to interact professionally within a client organization.
• Ability to prioritize multiple tasks and achieve project timelines.
• Shows commitment to and performs consistently high quality work.
• Effective time management in order to meet daily metrics or team objectives.
• Able to take initiative and work independently.
• Sense of urgency in completing assigned tasks.
• Able to travel a minimum of 65% on average.
• Holds a driving license and passport where required.

Education

• Educated to Degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience.

Language Skills

• Competent in written and oral English and fluent in relevant local language.

Minimum Work Experience

• Substantial monitoring experience in clinical research.

About ExecuPharm

ExecuPharm, A PAREXEL Company, is a Global Functional Service Contract Research Organization, who provides clinical research support services for the pharmaceutical industry. ExecuPharm’s distinctive business model incorporates flexible models of service and technologies to support every aspect of a clinical trial.

ExecuPharm, with a core management team with extensive clinical operations experience, understands clinical trial challenges and how to solve clinical outsourcing, staffing, placement, technology and process needs.
 
21+ years of Experience Meeting Client Needs
16,250+ Global Clinical Operational Specialists In Network
80% of Recruiting Staff with >15 Years of Experience
Talent Acquisition, Deployment Rates, and Employee Retention above 90%
Management Staff with Tangible Industry Experience
Greater Than 95% Repeat Business
Average Turnaround Time of 14 Days To Deploy Project Team Resources

 
Global Capabilities

ExecuPharm’s clinical operations specialists are well versed in country and regional customs, business practices as well as regulatory and ethical restrictions and considerations. Having a resource that knows the culture, speak the language and is close in proximity to trial sites will aid in resolving any issues pertaining to the trial in a fast and efficient manner. ExecuPharm global locations are as follows:
 
King of Prussia, Pennsylvania, United States - North America
Mexico City, Mexico - North America
Buenos Aries, Argentina - South America
Chichester, United Kingdom - Europe
Bangalore, India - Asia
Shanghai, China - Asia
Tokyo, Japan - Asia


Mission

ExecuPharm was founded with the goal to support the requirements of clinical studies for all pharmaceutical and biotech's around the world. ExecuPharm’s expertise in the placement of staff and the conduct and management of all phases of clinical research and full drug development is attributed to our operational efficiencies, transparency in our partnerships and effective, responsive client service. These core values take the everyday burden and challenges of clinical studies off the clinical team, management and all stakeholders involved leading to faster, more cost efficient execution of studies.
 

Timeline

ExecuPharm has grown organically and strategically since 1995
1995: ExecuPharm founded
2005: Expansion of core services to include functional outsourcing (FSP) recruitment for specific functional areas in clinical research
2006: Awarded trial management personnel augmentation program
2007: Awarded FSP for all trial management activities
2008/2009: Further developed clinical operations department, adding multiple senior leaders from midsized and major pharmaceutical companies Significantly expanded corporate infrastructure to increase capabilities in IT, HR, QA and Recruiting
Expanded functional outsourcing services to include monitoring and site management

2012: Expanded services, with offices, into Europe and Latin America
2013: Expanded services, with offices, into Japan, China, and India
2014: Expanded services, with offices, into Mexico
2016: Acquired by PAREXEL