Clinical Research Associate 1

Clinical Research Associate 1The Clinical Research Associate 1 (CRA 1) conducts site monitoring/management activities in accordance with regulations and department plans and procedures. Monitoring activities may be conducted in-house or by visiting sites. Monitoring visits may be co-conducted with more experienced personnel or conducted independently. May serve as primary or secondary clinical site contact on behalf of Hologic. Trains and maintains regular communication with site staff. Ensures adherence to protocol and accurate data recording. Confirms continued qualification of principal investigator, study staff, facilities and equipment. Identifies and resolves routine site issues. Writes timely monitoring visit reports and correctly manages study documentation.Facilitates distribution, collection and tracking of regulatory documents for site compliance and audit readiness. Conducts quality control (QC) review of study files and of data reports. May provide training and mentoring of Clinical Trial Assistants.Under frequent supervision and guidance, performs work that is varied and that may be somewhat difficult in character. All essential duties and responsibilities might be supported or overseen by more experienced personnel.Conducts Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)Ensures records are complete and consistent with governing regulationsAble to use or uses electronic data capture system and other monitoring tools to review and ensure accurate and complete clinical data collectionAssists sites with site-level IRB submissions, queries and documentationEstablishes and maintains regular communication with clinical sitesConducts on-site interim site monitoring activities including document review, source data verification, informed consent forms, other site documentation and study material accountability, as a co-monitor or independentlyPrepares and completes monitoring visit reports and letters and effectively documents site communications, independently or with some oversight from more experienced personnelIdentifies and addresses routine site issues including protocol deviations, subject recruitment and retention programs and communicates any observed study /data trends and proposed resolutionResolves non-routine site issues in conjunction with the Study LeadMay assist with the development of clinical trial documentsEnsures distribution, collection, and tracking of regulatory documents to ensure site compliance and audit readinessAssists in the validation and QC of clinical study database(s)Reviews Clinical Monitoring Plan, informed consent forms, template source documents, study manual, regulatory binder and other study-related documents; provides input as neededPerforms additional project tasks as determined by department and organizational needsWorks with frequent supervision, conferring with manager or Study Lead on a regular basisThe physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Sit; use hands to finger, handle or feel objects, tools, or controls.Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.Lifting/moving and carrying products weighing up to 40 pounds.Exposure to moving mechanical parts, vibration and/or moderate noise levels.Exposure to hazardous chemicals or other materials.Safety Shoes with Impact and Compression Protection Must be worn.Exposure to blood.Other (please specify): Travel 30-60%EducationBA or BS degreeExperience1-2 years of related experience. Experience with In Vitro Diagnostic (IVD) clinical studies a plus.SkillsWorking knowledge of clinical trial practices and regulationsWorking knowledge of clinical trial monitoring and site managementBasic knowledge of clinical trial databases and clinical data management systemsSome familiarity with clinical laboratory equipment and instrumentationIntermediate computer skills including Microsoft OfficeThe annualized base salary range for this role is $73,500 to $101,500 and the position is eligible for an annual bonus.Final compensation will depend on several factors, including relevant experience, skills, knowledge, geographic location, education, business needs, and market conditions.Equal Opportunity EmployerHologic is an Equal Opportunity Employer committed to fostering an inclusive workplace. We welcome qualified applicants regardless of race, color, religion, sex, national origin, age, disability, veteran status, or any other protected characteristic.M/F/D/V