IQVIA Jobs 2019

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

Job Description

Job Title: Sr CRA – Ghana

• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
• May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• May provide assistance with design of study tools, documents and processes.
• Convey features and opportunities of study to site.
• Collaborate and liaise with study team members for project execution support as appropriate.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Strong knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Good written and verbal communication skills including good command of English language
• Good organizational and problem-solving skills
• Effective time management skills
• Ability to manage competing priorities
• Good mentoring and training skills
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE 

Bachelor’s degree in a health care or other scientific discipline or educational equivalent and 2 years of on-site monitoring experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS   

• Extensive use of telephone and face to face communication requiring accurate perception of speech             
• Extensive use of keyboard requiring repetitive motion of fingers    
• Regular sitting for extended periods of time
• Requires frequent travel to sites