Job Description

Our client is a full-service Clinical Research Organization (CRO), a leading provider of Clinical research services & mission is Science with Integrity. It has fifteen years of impeccable regulatory history & has accumulated expertise in Early Phase (BA/BE), First in Man, Late Phase (various therapeutic areas), Respiratory, Tobacco Research, Dermatology, Consumer Research, Analytical lab, Diagnostic Central lab, IVRT, IVPT, Biometrics, Environmental Exposure Chambers, Pharmacovigilance and Medical Services.

This role is Full Time, permanent, Regionally Home Based position with around 70 to 75% travel from Apr 2022 Onwards (Based upon COVID-19 travel restrictions)

Responsibilities

• Prepare or submit or support other colleagues for Regulatory and EC submissions and in the generation of Financial Agreements according to standard and local country practices.
• Conduct monitoring visits as per the monitoring plan in order to check compliance with study management, protocol & other requirements at all assigned sites. Responsible for training of site study team regarding the monitoring plan, recording & maintenance of essential documents, and for startup activities & site initiation as per the guidance of Project Manager.
• Assist in the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures.
• Maintaining a working copy of the Central Investigator File & ensuring consistency with the Site Investigator File in order to maintain a working record of all essential documents and reports.
• Perform source document verification as per monitoring plan and ensure that source documents & other trial records are accurate, complete, kept up-to-date & maintained according to applicable SOPs to avoid incomplete records.
• Ensure timely collection of documents like CRF, DCF, etc. from the site along with SAE reports in order to provide Biometrics/licensing authority & others with the necessary documents.
• Responsible for study updates & Coordination with Labs & other trial-related services as per the study requirements.
• Responsible for IP accountability and availability, tracking and management of all Clinical Trial related supplies shipped to the sites/ warehouse & accordingly clinical trials supplies vendor management for the study.
• Ensure proper escalation of site/project-related issues to the Project Manager/ Designee in a timely manner.
• Responsible for site-closeout & follow-up activities in order to maintain documents at the site.
• Attend staff meetings and training sessions as required to complete the training curriculum in a timely manner.
• Assist with the audit of an investigational site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP and applicable regulatory guidelines.
• To liaise with other departments within the organization for timely achievement of the project milestones.
• Ensure to follow and adhere to organizations' general rules, policies, and applicable SOPs.
• CRA will review the study feasibilities and assist the PM in preparing the feasibility report/ tracking

Qualifications

• Bachelor's degree in life science or related field of study or equivalent combination of studies, and/or work experience
• 2+ years relevant experience, including substantial monitoring experience KNOWLEDGE
• In-depth knowledge of ICH-GCP guidelines, and applicable regulations, rules, and guidance, as applicable
• Keeps abreast of regulatory requirements and scientific knowledge and maintains technical expertise by reading relevant publications, attending courses, and through membership in relevant industry/professional associations SKILLS
• Proven IT proficiency and skills including Microsoft Office
• Effective problem solving, time management, and organization skills
• Effective verbal and writing skills; English and local language, if relevant
• This position requires the ability to perform varied tasks, maintain an appropriate work pace, exercise logic and reasoning, and comprehend and follow instructions
• This position requires the ability to travel 70 - 75%
  Performing the duties of this job regularly involves speaking and listening, repetitive hand movement (at least 15 minutes), and sitting for long periods of time; involves some standing, walking, grasping, reaching and lifting of up to 10 pounds