RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
The Sr. CRA is responsible for aiding the team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation. The position is responsible for tracking and supervising the collection of ongoing study data for the purpose of regular project status reporting as required.
Primary Responsibilities
- Conduct site monitoring visits (qualification and selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol, study specific documents and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol while maintaining adherence to applicable regulations and escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, diary and survey data and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training sign-off compliance visits
- Collaborate with study team members for project execution support as appropriate.
- May be accountable for supporting development of project subject recruitment plan on a per site basis
- May be accountable for site financial management according to executed clinical trial agreement and manage invoices according to local requirement
Requirements
- Bachelor's Degree in scientific discipline or health care preferred.
- Requires at least 4 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience considered.
- In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. MedTech regulations and active experience preferred.
- Strong therapeutic and protocol knowledge as provided in company training.
- ICU/CCU nursing background.
- CKRT/CRRT experience is desirable.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and mobile technology required.
- Written and verbal communication skills including command of English language.
- Organizational and pragmatic problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with co-workers, managers, sponsor staff and sites
Behaviours
- Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
Supervisory Responsibilities
- This position will have supervisory responsibilities.
Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!
We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
Job Opportunity Verification
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