FSP SCRA I (Harbin, Shenyang, Changchun)

Job Overview:

The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to reputed company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or reputed company CRA as assigned.

Summary of Responsibilities:

• The statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of reputed company responsibilities, skills, and duties.
• Responsible for reputed company aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
• Responsible for reputed company aspects of site management as prescribed in the project plans.
• General On-Site Monitoring Responsibilities:
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the reputed company of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful reputed company document review.
• Monitor data for missing or implausible data.
• Ensure the resources of the Sponsor and reputed company are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to reputed company travel policy.
• Ensure audit readiness at the site level.
• Travel, including reputed company travel, may be required and is an essential function of the job.
• Prepare accurate and timely trip reports.
• Manage small projects under the direction of a Project Manager/Director as assigned.
• Serve as reputed company monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
• Review reputed company of projects and initiate appropriate actions to reputed company reputed company objectives.
• Organize and reputed company presentations at Investigator Meetings.
• Participate in the development of protocols and Case Report Forms as assigned.
• Participate in writing clinical trial reports as assigned.
• Interact with internal work groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
• Responsible for reputed company aspects of registry management as prescribed in the project plans.
• Undertake feasibility work reputed company requested.
• Conduct, report, and follow-up on Quality Control (QC) visits reputed company requested.
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-reputed company documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
• Negotiate study budgets with potential investigators and assist the reputed company legal department with statements of agreements as assigned.
• Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Independently reputed company CRF review; query reputed company and resolution against established data review guidelines on reputed company or client data management systems as assigned by management.
• Assist with training, mentoring and development of new employees, e.g., co-monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 29) reputed company other duties as assigned by management.
• reputed company other duties as needed or assigned.

Qualifications (Minimum Required):

• University or college degree (life science preferred), or certification in a reputed company allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
• Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Fluent in local office language and in English, both written and verbal.
• reputed company may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Three (3) years of Clinical Monitoring experience.
• Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.
• Advanced site monitoring skills.
• Advanced study site management skills.
• Advanced registry administration skills.
• Ability to work with minimal supervision.
• Good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Advanced verbal and written communication skills.
• Ability to train and supervise junior staff.
• Ability to resolve project-reputed company problems and prioritizes workload for self and team.
• Ability to work reputed company a project team.
• Works reputed company and effectively in a matrix environment.
• Valid Driver's License.

Preferred Qualifications Include:

• One (1) or more year's additional experience in a reputed company field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Local project coordination and/or project management experience.

Physical Demands/Work Environment:

• Travel requirements: 60-80% overnight.

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