კომპანია SMO- Pharmina აცხადებს ვაკანსიას შემდეგ პოზიციაზე: კლინიკური კვლევის მონიტორი(CRA). სრული ინფორმაციისთვის იხილეთ ინგლისური განცხადება .
SMO-Pharmina is pleased to announce vacancy for following position: Clinical Research Associate (CRA). Please see the details below.
Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP), Protocol and International Conference on Harmonization (ICH).
Primary Key Responsibilities:
- Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and company/client SOPs for monitoring requirements.
- Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
- Collects and reviews regulatory documents as required.
- Prepares site visit reports and telephone contact reports.
- May participate in the start-up process including reviewing protocols, designing and/or reviewing CRFs and developing study documents.
- Resolves site issues, including site recruitment challenges and determines status for IP shipment.
- Works with Project Manager (PM), Clinical Team Leader and/or LCRA (CTL/LCRA), regulatory team members or sponsors to secure authorization of regulatory documents and site contracts.
- Attends Investigator Meetings (IM) and study specific training meetings.
- May translate, coordinate translations or review completed translations of critical documents.
- May participate in feasibility and/or site identification activities. Contact local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed.
- Performs internal in-house monitoring tasks.
- Prepares and attends an Assessment Visit with a more senior CRA, Clinical Team Leader or Clinical Research Manager as required.
- Assists the Project Team with the day-to-day monitoring of clinical studies as required, including attendance at team meetings.
- Reports directly to Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager.
- Collaborates with company and client project team members.
- Collaborates with company, client and local support personnel.
- Liaises with Investigators, Site Staff, Regulatory Authorities and Ethics Committees.
- Liaises with Sponsor scientific and medical personnel.
- Liaises with Vendors and Sub-contractors such as Central Laboratory and Courier organisations.
- Liaises with Quality Assurance personnel.
Education Requirements and Qualifications:
- Relevant life science medical / nursing degree or relevant degree or background preferred.
- 2-year experience of working on the same position
- Customer service orientation.
- Sound knowledge of medical terminology and clinical monitoring process.
- Attention to detail.
- Ability to perform travel depending on project needs.
- Excellent communication in English in both written and verbal skills.
- Computer literate and proficient in Microsoft Office.
- Excellent interpersonal and organizational skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects/tasks, establish and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients.
Qualified applicants should send CV firstname.lastname@example.org (please indicate at least one referee) no later than September 21, 2021 and indicate the position in the subject line.