Sr. Clinical Research Associate (Spain)
Allucent
- Madrid
- Permanente
- Tiempo completo
- Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
- Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
- Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
- Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
- Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
- Collect and review regulatory documents as required.
- Prepare site visit and telephone reports.
- Responsible for multiple projects and must work both independently and in a team environment.
- May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
- Resolve site issues and determine status for IP shipment.
- Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
- May translate, coordinate translations or review completed translations of critical documents.
- Participate in feasibility and/or site identification activities.
- Assist the Project Team with the day-to-day management of clinical studies as required.
- Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
- Train, mentor and/or supervise junior staff.
- May be assigned as LCRA to a regional or global study.
- May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
- Conducts project co-monitoring, assessment visits and team training.
- Site contact for protocol clarifications and subject enrolment if CRA unavailable.
- Participate in the development of study newsletters communication as required.
- Assist with the development of project-specific training materials for team.
- Liaise with Business Development and make presentations to potential clients as required.
- May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).
- At least 5 years experience.
- Skills to mentor and train other CRAs in a positive and effective manner.
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
- Ability to travel for up to 8 days on site per month, depending on the project needs.
- Strong therapeutic background.
- Has shown ability to successfully manage people/project issues.
- Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
- Demonstrates the ability to define and meet project requirements.
- Can demonstrate flexibility for improvement and creating solutions.
- Proven organizational abilities, and excellent written and oral communication and presentation skills.
- Excellent team player with team building skills.
- Strong customer focus.
- A thorough knowledge of regulatory submission and reporting requirements and guidelines.
- Excellent understanding of the drug development process.
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees