Sr. Clinical Research Associate (Germany)
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Job Summary
- Independently conduct and document onsite and remote activities including site monitoring and close-out visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance.
- Collaborate with site staff to review and ensure that the data reported in the applicable study system(s) is consistent with the source documents and compliant with study requirements.
- Monitor resolve and/or facilitate resolution of data queries and escalate issues as appropriate.
- Coordinate the shipment of clinical supplies including but not limited to investigational product laboratory supplies ePROs and study documents.
- Ensures site staff is trained in all aspects of the study including but not limited to the protocol study plans systems and ICH-GCP.
- Participate in routine study progress meetings teleconferences and Investigators meetings.
- Routinely review ISF and TMF for accuracy timeliness and completeness. Request documents from the site as required.
- Act as a primary contact for any questions or issues that arise from investigational sites.
- Oversee overall integrity of the study and promote positive working relationships with the site staff and study team members.
- Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
- Ensure all site related issues are followed until resolution including action items and protocol deviations.
- Coordinate delivery of clinical sites communications collaborating with project teams to ensure investigational sites are provided accurate ongoing data updates information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
- Regularly review the study related systems remotely to ensure compliance accuracy and completeness.
- Translate site documents for TMF filing when applicable.
- Routinely review the TMF for accuracy timeliness and completeness. Request documents from the site as required.
- Coordinate the shipment of clinical supplies including but not limited to investigational product laboratory supplies ePROs and study documents.
- Participate in audits/inspections and follow-up on issues and implement actions when required.
- Participate in routine study progress meetings and teleconferences.
- Identify and advise on site investigators selection independently conduct and document onsite and remote activities including site qualification and initiation visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance.
- Coordinate the shipment and delivery of clinical supplies including but not limited to laboratory supplies study documents and investigational product.
- Responsible for all site management activities related to site activation and work with the sites to meet clinical project timelines and milestones.
- Support the study Start-up team by following up on pending documents as needed.
- Support the Regulatory team by reviewing localizing and translating site documents as required.
- Optimize patient recruitment providing guidance and support to site teams to meet the site recruitment milestones.
- Participate in Investigators meetings.
- Mentor and support CRA I and II.
- Perform CRA Assessment Visits co-monitoring visits or visit sign-off process providing feedback.
- Assist the MSM hiring Manager by participating in interviews with candidates for the CRA position as requested.
- Participate in process improvement initiatives and contribute to the development of best practices.
MINIMUM EXPERIENCE REQUIREMENTS
4 - 6 years of related experience
PREFERRED EXPERIENCE REQUIREMENTS
7 9 years of related experience
MINIMUM EDUCATION REQUIREMENTS
(Honors) Bachelors degree
PREFERRED EDUCATION REQUIREMENTS
Masters degree
LANGUAGE REQUIREMENTS
Fluent in written and verbal English
Or an equivalent combination of education and experience may be considered.
Health Sciences Life Sciences Pharmacy or Nursing degree preferred or and/or ACRP Certification/Designation.
Experience with Phase IIV clinical trials is preferred.
Thorough knowledge of ICH-GCP and local regulatory requirements.
Proficient in using EDC systems (e.g. Medidata Rave Oracle InForm) IRT eTMF CTMS and Microsoft Office Suite.
Ability to travel up to 40-60% depending on project assignment and geographic location of sites.
Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams.
Great communication and organizational skills detailed orientation and sense of urgency are required.
Holder of a valid drivers license.
We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesnt feel right we encourage you to verify before responding.
Required Experience:
Senior IC
About Company
Accelerate your GI clinical trials with Alimentiv’s site network, clinical trial services, medical imaging, and biomarker discovery
