Clinical Research Associate 2
On-siteKarachi, Sindh, Pakistan
Job Summary
Conduct site monitoring visits, including selection, initiation, and close-out, ensuring adherence to Good Clinical Practice and ICH guidelines. Drive subject recruitment plans, administer protocol training, and escalate quality issues related to study conduct and regulatory compliance. Manage study progress by tracking regulatory submissions, enrollment, case report form completion, and data query resolution. Maintain Trial Master File and Investigator's Site File documentation while submitting regular visit reports and follow-up letters. Collaborate with the study team to support project execution and manage assigned study documents.
Required Qualifications
- Bachelor's Degree
- Degree in scientific discipline or health care preferred
- at least 1 year of on-site monitoring experience
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
- Good 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 and iPhone and iPad (where applicable)
- Written and verbal communication skills including good command of English language
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
- Good 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 and iPhone and iPad (where applicable)
- Written and verbal communication skills including good command of English language
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
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