Senior Clinical Research Associate

Job Description

POSITION SUMMARY:

Conducts monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. Performs management of study site activities to ensure the collection of accurate clinical data within given timelines. Carries out responsibilities with autonomy and independence while working in a team environment. Responsible for multiple studies. Position can be regional or office based.

PRIMARY JOB FUNCTIONS:

  • Manages all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity
  • Scientifically monitors clinical studies, which includes the review of case report forms (CRFs) and source documentation to ensure adherence to the protocol and consistency and scientific validity of the data
  • Provides full support including technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials
  • Assists the project team in development of study specific monitoring tools and other related documents as needed
  • Manages query resolution process with sites and Premier Research Data Management
  • Assists project team with assessing project feasibility and recruitment
  • Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
  • Maintains/reviews regulatory documents as required
  • Prepares for and attends project launch meetings
  • Assists the project team in the tracking of enrollment rates, receipt and review of completed CRFs and grant documentation to ensure the efficient execution of a clinical trial as required
  • May be involved in the preparation of documentation for submission to IRB/IECs and CAs as well as coordination of submission with appropriate site staff and /or Project Manager/Clinical Manager
  • Prepares Visit Reports and contributes information for Status Reports for sponsors
  • Assists in the preparation and development of materials for Investigators’ Meeting; participates in Investigators’ Meeting as designated by Project Manager
  • Manages investigative sites via telephone calls between visits
  • Ensures adherence to study timeline and budget
  • Coaches and mentors less experienced CRAs and assist in their development and training
  • Assists the Clinical Manager/Project Manager as required
  • Performs additional duties and assignments as requested

OTHER REQUIREMENTS:

  • Willingness to travel up to 70%, as required (additional travel is possible based on project requirements and availability)
  • Participates in company required training programmes
  • Valid driver’s license

Required Skills

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:

  • Demonstrates an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations
  • Demonstrates, understands and complies with Premier Research’s policies and procedures
  • Exhibits a strong knowledge base of medical terminology, clinical pharmacology and pathophysiology
  • Fluent written and verbal English language skills
  • Attention to detail and a methodical approach to work
  • Ability to organise and take initiative
  • Ability to handle and prioritize multiple assignments in a fast-paced work environment
  • Ability to identify issues proactively, identify resolutions and follow through to completion in an independent manner
  • Ability to communicate and negotiate at all levels
  • Ability to effectively interact with a variety of individuals including internal and external customers
  • Ability to work independently with minimal oversight as well as actively contribute to a project team
  • Maintain awareness of developments in the field of clinical research by reading relevant literature, attending clinical meetings, etc.
  • Proficient in the required computer skills including the ability to work with Microsoft Word, Excel, Outlook and ability to attain knowledge of other programmes, as needed
  • Recognised undergraduate degree in a clinical, science or related field or R.N. or equivalent work experience is required; a degree in Pharmacy, Biology, Chemistry, Psychology, Nursing or a related discipline is preferred
  • Candidate must demonstrate successful performance of CRA II level position (or equivalent position)
  • A minimum of 3 years clinical research experience as a monitor in the pharmaceutical, biotechnology or CRO industry OR
  • Two (2) years as a monitor plus minimum of two (2) years direct clinical research experience as a coordinator (e.g., study, data, compliance) OR
  • Two (2) years as a monitor plus a minimum of two (2) years experience at an RN level in critical care or in-patient hospital setting
  • Working knowledge of ICH-GCP/ISO14155 and relevant SOPs, as required
  • Working knowledge of FDA, European Regulatory and EC procedures, as applicable

Position Type

Full-Time/Regular

Contact

Interested candidates should submit their resume to: eugene.sidharto@premier-research.com