This position will be part of the Clinical Affairs Team, which is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Sr. CRA is responsible for site management deliverables on assigned protocols. With minimal supervision, the Sr. CRA manages the clinical monitoring activities of the study and assures site compliance with study protocols and applicable regulations and assists the Clinical Study Manager with study related activities, as required. The Sr. CRA may act as a lead CRA for the Sponsor.

We are offering a $10,000 sign on bonus to new hires for this role.

Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies.
• Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships.
• Serve as a point of contact for investigators and site staff. Maintains regular contact with study sites to ensure GCP/ICH/Protocol compliance and assessment of accrual rates.
• Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables.
• Support the Clinical Study Manager to develop study-specific training materials.
• Conduct thorough site qualifications visits. Ensures all required information concerning site/staff qualifications is clearly documented and communicated to project teams.
• Conduct efficient and comprehensive site initiation visits. Ensures all assigned site staff are trained appropriately, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.
• Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintains a flexible monitoring schedule (as appropriate) and assists in co-monitoring or monitoring support of clinical sites/studies.
• Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensures all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicates the issues and suggested resolutions to the Clinical site and project team.
• Conduct device/product accountability responsibilities at clinical sites; Identifies, clearly communicates and documents issues to the clinical site and project team. Assists clinical site in resolving issues, if appropriate.
• Participate in all aspects of site close-out activities (i.e. evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicates status of Site management activities on a routine basis to the Clinical Project team and management.
• Participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and in-house and regional CRA team members.
• Assist with the creation of protocol, CRFs, and all other associated study documents.
• Support the Clinical Study Manager to develop, implement and execute, the clinical study Monitoring Plan. Ensure compliance with the plan and all assigned tasks throughout the study.
• Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members.
• Communicate project specific information to/from trial sites through teleconferences, newsletters, etc.
• Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis.
• Document monitoring activities in monitoring visit reports and follow-up letters.
• Communicate serious issues to appropriate parties, in a timely manner.
• Ensure operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
• Work with clinical study manager to manage vendors (ie. Central Laboratory, CRF printers, CROs, etc).
• Present at and participates in Investigator Meetings, and other study trainings and meetings as required. Trains CRAs on protocol requirements as required.
• Mentor and train CRA I and/or CRA II colleagues. May provide mentorship to the Clinical Affairs Associate team.
• Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
• Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
• Ability to manage multiple deadlines.
• Must be highly organized and able to produce high quality work independently or as a part of a team and be able to multi-task and work in a high volume, deadline-controlled environment.
• Must have excellent writing, verbal communication, interpersonal and diplomacy skills.
• Strong leadership and diplomacy skills in a team environment.
• Must have high degree of accuracy and attention to detail.
• Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff.
• Strong desire to work in a fast-paced environment.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to lift up to 10 pounds for approximately 5% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability and means to travel between Madison locations.
• Ability to travel 50% of working time away from work location, may include overnight/weekend travel.

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Minimum Qualifications:

• Bachelor's degree in the life sciences field or a related field.
• 5+ years of clinical research experience.
• 3+ years of monitoring experience.
• Excellent understanding of ICH GCP and monitoring practices with a track record for ensuring quality data and performing outstanding site management, including site audits and preparation.
• Knowledge of Good Clinical Practices and all applicable US regulations governing clinical research.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications:

• IVD/medical device monitoring.
• Working knowledge of the FDA submission process including IDE, PMA, and 510(k).

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.