Experienced Clinical Research Associate
A multi-national contract research organisation (CRO) is offering a vacancy for an Experienced Clinical Research Associate. The company offers a wide range of comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries, from Phase 1 through to IV. This position will be home-based and offer an exciting opportunity to work with a leading international organisation that prides itself on its global reach. This position will be home based.
- Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule.
- Adheres to project guidelines and company SOPs for monitoring requirements.
- Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
- Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.
- 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, reviewing CRFs, preparing Informed Consent forms, developing study documents, and organizing and presenting at investigator meetings.
- Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
- Assists the Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission.
- Works with PM/CTL/LCRA to secure authorization of site contracts.
- Informs team members of completion of regulatory and contractual documents for individual sites.
- Attends Investigator Meetings (IM) and study specific training meetings.
- May translate, coordinate translations or review completed translations of critical documents.
- Participates in feasibility and/or site identification activities.
- Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation.
- Follows the feasibility procedures for documentation of feasibilities performed.
- Identifies the documentation required for review by Regulatory Authorities and Ethical Committees. Prepare Regulatory and Ethics Committee submissions.
- Ensures written approvals are obtained and distributed appropriately prior to Site Initiation.
- Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
- Conducts Assessment and/or Training Visits of CRA I/II as required.
- Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings.
- Organizes processes for interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with Pharm-Olam accountant, logging trial expenditure, receipts, invoices and income.
- Provides secondary in-house review of CRFs (if required).
Skills and Requirements:
- At least three years clinical monitoring experience and/or relevant clinical trial experience in CRO or Pharmaceutical company.
- Relevant life science degree/medical/nursing background or equivalent.
- Fluency in German and English.
- Sound knowledge of medical terminology and clinical monitoring process.
- In-depth therapeutic and protocol knowledge as provided in previous or company provided training.
- Ability to perform travel an average of 25%, depending on project needs.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani at +44 203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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