Syneos Health Hiring Clinical Research Associate I (Mumbai)

Syneos Health Hiring Clinical Research Associate I (Mumbai)

Syneos Health, a globally recognized biopharmaceutical solutions organization, is looking for a Clinical Research Associate I to join their Mumbai-based team. With over 29,000 employees across 110 countries, Syneos Health is dedicated to accelerating the delivery of innovative therapies that change lives. This role offers an opportunity to work on various aspects of clinical research including site qualification, site management, and compliance monitoring.

Job Location

• Location: Mumbai, India
• Type: Client-Based
• Job ID: 24003699

Vacancy Information

Position: Clinical Research Associate I (CRA I)
Location: Mumbai
Department: Clinical Development
Contract Type: 6-month contract, client-based
Travel Requirements: Up to 75%
Experience Required: Knowledge of Good Clinical Practice (GCP) and ICH guidelines, excellent communication and interpersonal skills, and proficiency with new technologies.

Responsibilities

As a Clinical Research Associate I at Syneos Health, you will play a pivotal role in the management and monitoring of clinical trials. Responsibilities include:

• Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of the site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and, with guidance, develops action 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 each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site, such as protocol deviation/violations and pharmacovigilance issues.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP):
  • Assesses site processes
  • Conducts Source Document Review of appropriate site source documents and medical records
  • Verifies required clinical data entered in the case report form (CRF) is accurate and complete
  • Applies query resolution techniques remotely and on-site and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
  • Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
  • Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labeled, 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 aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip 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 track all observations, ongoing status, and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables, and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals/targets.
• May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all 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 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.
• For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:
  • Site support throughout the study lifecycle from site identification through close-out
  • Knowledge of local requirements for real-world late phase study designs
  • Chart Abstraction activities and data collection
  • Collaboration with Sponsor affiliates, medical science liaisons, and local country staff

For Real-World Late Phase studies, CRA I may have additional responsibilities, such as site support throughout the study lifecycle, chart abstraction, and collaboration with medical science liaisons.

Qualifications

Syneos Health is looking for qualified candidates with the following credentials:

• Education: Bachelor’s degree or Registered Nurse (RN) qualification in a related field.
• Experience: Familiarity with Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
• Technical Skills: Proficiency with computer systems and ability to adapt to new technologies.
• Communication Skills: Excellent interpersonal, communication, and presentation abilities.
• Travel Requirements: Must be able to travel up to 75% as part of the role.

How to Apply

Ready to take the next step in your career with Syneos Health? Apply today by visiting Syneos Health Careers.

Tagged as: Good Clinical Practice (GCP)