Sr Staff Clinical Research Associate

Provides clinical support for diagnostic product development to achieve clearances and approvals in the US and internationally. Provides clinical trial site management and assures successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures. Reviews, assesses and interprets data from ongoing and completed studies. Conducts clinical compliance activities. May be responsible for multiple clinical studies.

location: Telecommute
job type: Contract
salary: $66.75 - 83.50 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Responsible for the day to day management of clinical trial sites across multiple clinical projects.
• Identifies and builds relationships with external clinical sites.
• Manages multiple clinical trials in parallel including investigator selection, analysis of potential enrollment, preparation of trial related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements, etc.) and organize investigator's start-up meetings.
• Works with business development to contract external sites, as required.
• Submits protocols and other documents to Institutional Review Boards / Ethics Committees with follow through to ensure successful outcome.
• Monitors the assigned clinical trials following company SOPs and in accordance with GCP and all FDA and applicable international regulations concerning clinical trial activities.
• Assists in preparation of study-specific binders, logs and forms.
• Plans the requirements for clinical trial material, orders clinical trial material, sets up and monitors the systems whereby the clinical project coordinator can ship clinical trial material to the investigator, maintains procedures to account for the clinical trial material, checks the expiration of clinical trial material and requests extensions if necessary.
• Manages enrollment strategies to meet study requirements (e.g., investigator and study coordinator meetings, newsletters, advertising, etc.).
• Coordinates shipment of clinical samples and the resulting data when central laboratory facilities are used.
• Tracks completed CRFs and sets up systems whereby completed CRFs are rapidly entered into the database. Ensures that queries generated during data cleaning are responded to in a timely fashion.
• Evaluates clinical data/information and prepares reports as required.
• Participates in conference calls and meetings to review progress of ongoing clinical trials.
• Reviews all UADEs, ensures appropriate approvals are obtained, that sites are notified and that all company procedures are complied with.
• Maintains project files including: ethics committee approvals; curricula vitae of investigators and study personnel; package insert and user guides; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
• Participates in the conduct of internal and external audits and inspections of clinical studies. Participates in departmental planning sessions, and SOP development.
• Mentors junior CRAs to promote departmental skill base.
• Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

qualifications:
Education & Experience

• Bachelor's Degree in a life science, health-related field, or equivalent. A Master's Degree or PhD is highly preferred.
• Proven experience in clinical trial site management across multiple clinical projects, specifically within the diagnostic product development space.
• Demonstrated success in achieving US and international regulatory clearances and approvals for diagnostic products.

Core Competencies & Skills

• Clinical Trial Lifecycle Management: Expertise in overseeing the entire clinical trial process, including investigator selection, enrollment analysis, and comprehensive trial documentation (protocols, CRFs, consent forms, letters of agreement). Ability to manage multiple clinical studies in parallel from start-up to completion.
• Site Relationship Building: Strong track record of identifying, engaging, and fostering relationships with external clinical sites . Experience working collaboratively with business development for site contracting.
• Regulatory & Compliance Acumen: In-depth knowledge and practical application of Good Clinical Practice (GCP), FDA regulations, and relevant international guidelines . Proficient in submitting protocols to IRBs/Ethics Committees and ensuring successful outcomes.
• Clinical Monitoring & Data Integrity: Skilled in monitoring assigned clinical trials to ensure adherence to SOPs and regulatory standards. Experience with tracking CRFs, managing data entry, and resolving data queries efficiently.
• Clinical Trial Material & Sample Management: Experience in planning, ordering, and managing clinical trial materials , including shipping, accountability, and expiration date tracking. Competence in coordinating the shipment of clinical samples and associated data to central laboratories.
• Enrollment Strategy Development: Ability to design and implement effective enrollment strategies to meet study timelines and objectives.
• Reporting & Analysis: Capable of evaluating clinical data, interpreting findings, and preparing comprehensive reports . Active participation in project review meetings and conference calls.
• Safety Reporting & Documentation: Experience with reviewing and managing Unanticipated Adverse Device Effects (UADEs) , ensuring proper approvals, site notifications, and procedural compliance. Meticulous in maintaining comprehensive project files for regulatory and audit readiness.
• Quality Assurance & Mentorship: Participation in internal and external audits/inspections of clinical studies. Willingness to contribute to departmental planning and SOP development, and a desire to mentor junior Clinical Research Associates (CRAs) .

#LI-CV1

skills: CRF, Clinical research, GCP (Good Clinical Practice), COV (Close-Out Visit), CTMS (Clinical Trial Management Systems), EDC (Electronic Data Capture), PSV (Pre-Study Visit), RMV (Routine Monitoring Visit), SIV (Site Initiation Visit), TR (Trip Report), ICH Regulations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ....

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

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We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.