We are searching for an experienced Clinical Research Coordinator (CRC). The CRC will
work as an integral member of APIC/PRU Clinical Research site staff maintaining the day-to-
day relationship with patients and assist in the development of study documents. This
includes planning, coordinating and, as appropriate, execution of clinical studies in
accordance with the protocol, contracted scope of work, Sponsor, CRO, APIC/PRU SOP’s
and any relevant local guidelines and regulations. The Clinical Research Coordinator will
plan, direct, or coordinate clinical research projects. In addition they will be expected to direct
the activities of workers engaged in clinical research projects to ensure compliance with
protocols and overall clinical objectives.
Primary Responsibilities:
- Work directly at patient/subject interface at research sites (multiple location) to deliver high quality patient data in accordance with local regulations, agreed scope of work and as required by protocol.
- Attend and participate in investigator meetings, monitoring visits, audits, seminars and other regional or national meetings.
- Assist with screening and enrollment of subjects into assigned studies.
- Support subjects on trials to encourage maximum retention and future recruitment.
- Assist with the establishment of a recruitment plan for each study.
- Assist investigator with recording and reporting of adverse events and SAE’s as per local regulatory authority guidelines.
- Communicate effectively across all departments company-wide providing information by telephone, in written form, e-mail, or in person.
- Participate in the writing and review of study documents, including but not limited to protocols, informed consent forms, regulatory reports and study reports for assigned clinical studies.
- Contribute to the design, development and testing of the case report forms for assigned clinical studies.
- Participate in site IRB and country regulatory submission and approval internally or with vendor.
- Participate in the review of the site-level documentation for assigned clinical studies.
- Participate in the preparation and review of service agreements and study specific agreement for assigned clinical studies.
- Participate in monitoring and tracking budget and expenses for assigned clinical studies.
- Assists with developing study timelines and study budgets for assigned clinical studies.
Required Knowledge, Skills and Abilities:
- Sound knowledge of medical terminology
- Sound knowledge of ICH/GCP and Regulatory requirements.
- Excellent interpersonal and organizational skills.
- Proficient in the use of Microsoft Office and Excel.
- Fluent in English, spoken and written.
- Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
- Ability to maintain confidentiality.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Minimum Required Education, Experience, and Certifications:
- Pharm D or Pharmacy.
- Certification in Clinical Research is a plus.
- Clinical Research experience in clinical trials is a must (2-3 years).
If your qualifications meet our criteria please submit your resume at:
info@pru.com.jo
