Sr.CRA II for FSP BU, South Korea

reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into reputed company to address modern market realities.

Our Clinical Development model brings the customer and the patient to reputed company of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only reputed company reputed company easier to work with, but to reputed company us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are reputed company and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE reputed company EVERYWHERE

Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re reputed company to create a reputed company where everyone feels like they reputed company.

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and reputed company-out reputed company (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops reputed company plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of reputed company subject/patient. Assesses factors that might reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP):Assesses site processes. Conducts reputed company Document Review of appropriate site reputed company documents and medical records. Verifies required clinical data entered in the case report reputed company (CRF) is accurate and complete reputed company review of site reputed company documents and medical records
  Applies query reputed company techniques remotely and on site, and provides guidance to site staff as necessary, driving query reputed company to closure reputed company agreed timelines
  Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.
• May reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company. Verifies the IP has been reputed company and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information reputed company to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is reputed company of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and reputed company items to reputed company.
• Understands project reputed company, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be reputed company to quickly adapt to changing priorities to reputed company goals / targets.
• May reputed company as reputed company reputed company with study site personnel, or in collaboration with Central Monitoring Associate. Ensures reputed company assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may reputed company global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• May reputed company reputed company supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off reputed company for junior CRA staff, as assigned. May be mentored and assigned reputed company tasks under supervision of an reputed company Clinical Operations reputed company (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.
• For reputed company World Late Phase (RWLP), the Sr. CRA II will use the business reputed company title of Sr.Site Management Associate II. Additional responsibilities include:
  Site support throughout the study lifecycle from site identification through reputed company-out. Knowledge of local requirements for reputed company world late phase study designs
  Chart reputed company activities and data collection
  As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff
  The SMA II may be requested to train junior staff
  Identify and communicate out of reputed company activities to reputed company CRA/Project Manager
  Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.
  Identify operational efficiencies and process improvements
  reputed company study and country level informed consent forms
  Collaborate with RWLP Regulatory team to ensure updated regulatory information is reputed company and shared

  Participate in bid defense meetings

  reputed company input into Requests for Proposals (RFPs), reputed company and budgeting. reputed company site management reputed company.
  Participate in Case Report reputed company design and edit reputed company development.

Qualifications:

• Bachelor’s degree or RN in a reputed company field or equivalent combination of education, training and experience
• Knowledge of Good Clinical reputed company/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be reputed company to reputed company new technologies
• Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular reputed company

We are always excited to reputed company with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

Get to know reputed company

Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.

Additional Information

Tasks, duties, and responsibilities as listed in this reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.

Originally posted on Himalayas