Senior Clinical Research Associates (SCRAs) in Oman, Lebanon, UAE and Jordan.

Posted on April 12, 2018
Overview

Phoenix Clinical Research is recruiting Senior Clinical Research Associates (SCRAs) in Oman, Lebanon, UAE and Jordan.

Title

Senior Clinical Research Associate (SCRA)

Principal Duties and Responsibilities

  • Maintains knowledge and ensures compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs, project specific procedures and project scope, budget, etc. (e.g. Project and Monitoring Plan)
  • Ensures timely completion of role-based and project-specific trainings
  • Supports timely selection of qualified investigational sites (with clinical project manager/project team)
  • Builds strong and lasting relationships with site investigators and site teams/staff
  • Schedules, plans, prepares for and then performs site monitoring visits according to the monitoring plan and SOPs to ensure appropriate monitoring activities are completed at each onsite or remote visit (e.g. SDV, site staff training, investigator site file review, compliance checks, drug accountability, observational visits, facility review, etc.).
  • Applies judgment and knowledge to independently resolve sites issues, questions and concerns
  • Provides timely updates to tracking systems/clinical trial management system (CTMS) as needed
  • Collects, compiles and reviews new/updated/amended site regulatory package (SRP) documents in collaboration with Clinical Trial Specialists (CTS)/project team on an ongoing basis
  • Submits to and follows up with site staff on Clinical Site Agreements (CSA) (including budget), and site-specific Informed Consent Forms (ICF)
  • Provides prepared EC package to the Principal Investigator (PI) for submission and follows up to secure approval where required
  • Plans and evaluates patient recruitment, reviews and provides updates to applicable project tracking systems
  • Reviews subject safety data and AEs/SAEs and ensures appropriate follow-up and escalation according to protocol/regulatory requirements
  • Responds to site issues, ascertains and recommends appropriate follow-up response to issues including potential deficiencies in documentation, communication, and the need for additional training
  • Evaluates overall compliance and performance of sites and site staff: provides recommendations regarding site-specific actions and uses judgment and experience to assess the ability and motivation of site staff
  • May assist Project Manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members.
  • Other duties as needed or required

Supervision Received

The candidate should report to the Line Manager, with regular/close supervision.

Requirements

  • Bachelor’s degree in a science-related field or equivalent certification/licensure from an appropriately accredited institution
  • Minimum 3 years of experience as CRA (clinical research monitoring experience that provides the required knowledge, skills and abilities and experience mentoring or training others)
  • Valid Driver’s License where applicable
  • An equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered
  • Deals with confidential information and/or issues using discretion and judgment

Other Qualifications & Skills

  • Effective clinical monitoring skills
  • Excellent understanding and demonstrated application to FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
  • Ability to mentor and train other monitors in a positive and effective manner
  • Ability to evaluate medical research data and proficient knowledge of medical terminology
  • Excellent interpersonal skills
  • Strong attention to detail
  • Effective organizational and time management skills
  • Proven flexibility and adaptability
  • Excellent team player with team building skills
  • Ability to work independently as required
  • Ability to utilize problem-solving techniques applicable to constantly changing the environment
  • Effective verbal and written communication skills, with the ability to communicate effectively with medical personnel
  • Good command of English language and grammar
  • Flexibility to travel
About Phoenix Clinical Research

Phoenix Clinical Research is a regional full-service CRO established in Lebanon. It covers the entire Middle East and North Africa region with a unique service profile that combines the flexibility and responsiveness of a growing and dynamic CRO entity. With a solid expertise of more than 13 years of international and Middle Eastern clinical research experience, it is one of the few to have the local Middle Eastern in addition to Western expertise. Phoenix CR aims to work with biopharmaceutical and healthcare experts in every field, such as but not limited to, medical writing, biostatistics, health economics, regulatory services, clinical trials monitoring and management.