• Senior Clinical Research Associate

    Job Locations US-WI-Madison | US-MA-Boston | US-CA-San Diego | US-MN-Minneapolis | US-NC-Raleigh
    Req No.
    2018-3090
    Category
    Clinical Operations
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    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 Senior Clinical Resarch Associate is responsible for site management deliverables on assigned protocols. With minimal supervision, the Senior Clinical Resarch Associate 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. This role may act as a lead CRA for the Sponsor.

    Essential Duties and Responsibilities

    • Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies.
    • Conducts oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships.
    • Serves 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.
    • Facilitates 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.
    • Supports the Clinical Study Manager to develop study-specific training materials.
    • Conducts thorough site qualifications visits. Ensures all required information concerning site/staff qualifications is clearly documented and communicated to project teams.
    • Conducts 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.
    • Ensures 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.
    • Conducts 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.
    • Conducts 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.
    • Participates 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.
    • Actively participates 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.
    • Assists with the creation of protocol, CRFs, and all other associated study documents.
    • Supports the Clinical Study Manager to develop, implement and execute, the clinical study Monitoring Plan. Ensures compliance with the plan and all assigned tasks throughout the study.
    • Ensures 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.
    • Communicates project specific information to/from trial sites through teleconferences, newsletters, etc..
    • Works with clinical project manager to assure investigator payments are appropriate and paid on a timely basis.
    • Documents monitoring activities in monitoring visit reports and follow-up letters.
    • Communicates 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.
    • Works with clinical study manager to manage vendors (ie. Central Laboratory, CRF printers, CROs, etc.).
    • Presents 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 use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
    • Ability to sit and/or stand for an extended period of time.
    • Ability and willingness to travel (by land and air), both domestically and internationally, minimum of 50%. May include travel with minimal advanced notice.
    • 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.
    • Ability to lift and move up to 40 pounds on an occasional basis.

    Qualifications

    Minimum Qualifications

    • Bachelor’s degree in a health or life sciences field, or a related applicable field.
    • 5+ years of clinical research experience.
    • 3+ years of monitoring experience.
    • Demonstrates 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.
    • 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.
    • Demonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process including IDE, PMA, and 510(k).
    • 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.

    Preferred Qualifications

    •  IVD/medical device monitoring experience.

    #LI-KE1

    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.

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