Job Summary
- The Clinical Research Associate 2 (CRA 2) independently conducts site monitoring/management visits in accordance with regulations and department plans and procedures. Serves as primary 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 site issues. Writes timely monitoring visit reports and correctly manages study documentation.
- Assists Study Lead with the development of clinical trial documents. Facilitates distribution, collection and tracking of regulatory documents for site compliance and audit readiness. Assist Study Lead with subject recruitment and retention programs. Conducts quality control (QC) review of study files, and data reports. May provide training and mentoring of Clinical Trial Assistants and less experienced CRAs. Interacts with other functional areas to identify site issues and create mechanisms for solving problems as needed.
Essential Duties and Responsibilities
Under moderate supervision and guidance, performs work that is varied and that may be somewhat difficult in character.
- Conducts Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities independently and 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 regulations
- Able to use or uses electronic data capture system and other monitoring tools to review and ensure accurate and complete clinical data collection
- Assists sites with site-level IRB submissions, queries and documentation
- Establishes and maintains regular communication with clinical sites
- Conducts on-site interim site monitoring activities independently including document review, source data verification, informed consent forms, other site documentation and study material accountability
- Prepares and completes monitoring visit reports and letters and effectively documents site communications
- Identifies and addresses routine site issues including protocol deviations, subject recruitment and retention programs and communicates any observed study /data trends and proposed resolution
- Resolves non-routine site issues in conjunction with the Study Lead
- May assist with the development of clinical trial documents
- Ensures distribution, collection, and tracking of regulatory documents to ensure site compliance and audit readiness
- Assists 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; providing input as needed
- Performs additional project tasks as determined by department and organizational needs
- Works with moderate supervision, conferring with manager or Study Lead occasionally
Physical Demands (Please check all applicable boxes)
The 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%
Qualifications
Education
Experience
- 2+ years or related experience. Experience with In Vitro Diagnostic (IVD) clinical studies a plus.
Skills
- Intermediate knowledge of clinical trial practices and regulations
- Demonstrated experience in independent clinical trial monitoring and site management
- Proficient use of clinical trial databases and clinical data management systems
- Familiarity with clinical laboratory equipment and instrumentation
- Proficient computer skills including Microsoft Office
The annualized base salary range for this role is $80,700 to $126,100 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.
Agency and Third-Party Recruiter Notice
Agencies submitting candidates to Hologic must have a current, executed Hologic Agency Agreement approved by a member of the Human Resources Department. Agencies may only submit candidates for positions to which they have been specifically invited by a Hologic Recruiter. Any resumes submitted outside of these terms will not be considered.
Equal Opportunity Employer
Hologic 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