Clinical Research Associate

Medical, Clinical & Science         ·          New York, NY        ·       Full time

Who We Are:

Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for patients with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program has entered a pivotal, fully remote, randomized, controlled trial on the Verily platform for the treatment of Major Depressive Disorder (MDD) in up to 360 adults. Click is progressing a broad pipeline of Digital Therapeutics™ across a variety of high-burden therapeutic areas, including MDD, Schizophrenia, Migraine, MS, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome (ACS), Obesity, Oncology and more.

About the Role:

The Clinical Research Associate (CRA) is responsible for supporting and performing monitoring and site management activities for traditional, remote or decentralized clinical research studies. The CRA ensures research projects are conducted, recorded, and reported in accordance with the protocol, sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements. The CRA performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.  

This position is based out of Click’s headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities.

Responsibilities

• Responsible for performing monitoring and site management activities for traditional, remote or decentralized clinical research studies
• Contribute to the review and quality assessment of Study Synopses, Protocols and Investigator Brochures
• Contribute to the development, review and management of Standard Operating Procedures, Work Instructions, Forms and Templates
• Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
• Proactively identify and resolve and/or escalate study related issues
• Coordinate contract vendors and Clinical Research Organizations activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs
• Oversee investigational site startup activities, including the preparation and review of study documents (e.g., ICFs, CRFs, study manuals, study binders, etc.), reviewing/approving essential regulatory document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies
• Conduct remote and on-site monitoring visits to oversee CRO personnel and study conduct at the investigator sites
• Participates in project team meetings and conference calls to review progress of ongoing clinical trials
• Ensure the Clinical Trial Master System (CTMS) and Trial Master File (TMF) are maintained in an inspection-ready state; review for compliance and address findings as needed
• Assist with management and accountability of clinical trial supplies, including Investigational Product, research specimen samples and/or fMRI scans
• Ensure appropriate CRF completion and review and approval of clinical trial site monitoring reports

Qualifications

• Bachelor’s Degree or equivalent required from top-tier university, typically in nursing or scientific field
• 2+ years’ experience as a Clinical Research Associate in a biotech, pharma, or CRO setting
• Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology
• Ability to deliver results and execute on required activities individually, in a team setting
• Organized and detail-oriented
• Strong communication skills in a compact clinical team working with aggressive timelines
• Ability to travel up to 20%, generally within the US
• Highly responsive and proactive team player with a desire to bring leadership skills into a rapidly growing company

Benefits

The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space. 

Stock options | Competitive Salary with Annual Review | 5% 401(k) matching | Annual Performance-Based Cash Bonus | Comprehensive Medical Benefits | Dental | Vision | Voluntary Benefits | Unlimited Vacation Time | Uber One | Nectar Rewards | One Medical | Fertility Support | Gym Pass | Citi Bike | Professional Development Stipend | Industrious Workspaces | Generous Paid Parental Leave | Commuter Subsidies | Weekly Catered Lunches | Choice of Mac or Windows | Sponsored Company Events | Free, Unlimited Office Snacks and Beverages | Much More…

Equal Employment Opportunity:

Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague’s long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague’s temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the “at-will” employment relationship between the colleague and Click Therapeutics.

Recruitment Phishing Scams: 

As recruitment phishing scams are growing, we urge you to be vigilant during the job search process. Please be mindful of the following:

• Click Therapeutics will only reach out to you through an “@clicktherapeutics.com” email address.
• Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver’s License Number) via email or a messaging application (like that used on the LinkedIn platform).
• Click Therapeutics will conduct interviews face-to-face over Zoom.
• All job postings will be listed on the Click Therapeutics official career page. If someone contacts you about a job or position that is not listed on the official career page, please contact the Click Therapeutics recruitment team at the contact information below.
• If you have any questions regarding the validity of a recruitment inquiry or an interview, please contact the Click’s recruitment team at recruitment@clicktherapeutics.com to confirm before proceeding.

Please click here to apply.