Senior Clinical Research Associate

I. PURPOSE OF JOB:

The Senior Clinical Research Associate (CRA) is accountable for the day-to-day operational activities of one or more clinical trials including trial start-up, conduct, monitoring and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically may be coordinated in conjunction with one or more CROs. The Sr. CRA will support study mangers and clinical development team members as a first point of escalation for study related matters.

The individual must have the ability to work independently with limited supervision. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

II. MAJOR DUTIES AND RESPONSIBILITIES:

Manage multiple clinical studies and/or sites to facilitate trial deliverables and assure timelines are met. This includes accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials.
Ensure clinical studies are carried out in compliance with Sight Sciences Inc. corporate policies and procedures, applicable regulatory guidelines, standards, laws and regulations.
Under the supervision of a Study Manager, contribute to study design, development, conduct and closure.
Assist in the creation, review and/or revision of key study documents, including but not limited to protocol, investigator brochures, informed consent document templates, monitoring plans, annotated monitoring visit report templates, and other trial tools.
Assist or participate in identification and evaluation of potential investigators and investigative sites for assigned clinical trials.
Responsible for study start-up activities including managing essential trial documents.
Serve as primary contact for assigned investigative sites.
Collaborate with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
Coordinate Institutional Review Board (IRB) and/or Ethics committee submissions (EC), as appropriate.
Train investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, and applicable local and national regulations.
Under the supervision of a Study Manger, evaluate enrollment against assigned targets and work with sites to meet, and/or exceed enrollment targets.
Assess eCRFs or study database for trends in safety, and adherence to protocol. This includes identifying potential issues or inconsistencies that could signal problems with data collection or monitoring.
Perform on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include but not limited to:
Ensuring that all clinical trial documentation is properly reviewed, approved and filed within the study record or Trial Master File, Investigator Site File and is accessible the clinical team and investigative site personnel.
Ensure proper handling and documentation for investigational product and clinical supplies.
Complete monitoring visits within the timeframe defined by the monitoring plan.
Prepare, submit and file monitoring visit reports and associated follow-up letters as specified in the Monitoring Plan.
Provide regular study updates to investigative sites, Study Manager and the rest of the study team with respect to study conduct and compliance.
Escalate site non-compliance and issues as appropriate.
Maintain current knowledge of overall progress of clinical trials by regularly attending project and/or clinical trial team meetings.
Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
Participate in the development of process changes/improvements. III. EDUCATION REQUIREMENTS:

Bachelors Degree required. Degree in biological, nursing or other science degree preferred. IV. EXPERIENCE REQUIREMENTS:

3-5 years of clinical research experience in the biotechnology/biopharmaceutical industry with at least 2 years of independent field monitoring experience.
Knowledge of ophthalmology is preferred.
Knowledge of FDA Regulations, ICH Guidelines, ISO standards, and GCP governing the conduct of clinical studies. Familiarity with EMEA/EMA guidelines is a plus.
Proficient computer skills with MS Office PowerPoint, Word, Excel, Outlook and the ability to learn new software programs is required.
Autonomous, self-starter with impeccable time management skills, with the ability to successfully manage multiple competing priorities and adapt quickly to changing priorities.
Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings is preferred
Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
Self-motivated, with initiative and the ability to take ownership of, and follow through with, assigned tasks.
A team player with demonstrated flexibility and adaptability. V. OTHER QUALIFICATIONS:

Willingness and ability to travel up to 75% of the time, depending on the study needs. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)