Senior Clinical Research Associate
Who We Are
Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people 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 is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Major pipeline expansion and progression is in process.
About the Role
The Senior Clinical Research Associate (Sr. CRA) is responsible for performing monitoring and site management activities for traditional, remote or decentralized clinical research studies. The Sr. 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 Sr. 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 is an exciting opportunity for an experienced CRA who would like to expand his/her skill set and explore other job functions in Clinical Operations. The Sr. CRA will assist with clinical activities related to one or more clinical trials and performing or managing daily in-house and on-site operations associated with these trials. This position is responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities. This position will provide a high level of engagement in developing study specific documents and department operations guidance documents.
This is a highly visible, creative, and agile role within a rapidly growing pre-IPO company in a nascent and fast-growing space. The role will be located in our trendy TriBeCa HQ, includes great benefits, and is an excellent wealth-building/equity opportunity for the right individual.
Responsibilities
- Responsible for performing monitoring and site management activities for traditional, remote or decentralized clinical research studies
- Responsible for performing additional Clinical Operations and study management tasks, as required
- Provide strategic assessment of study timelines and progress prior to and during study conduct
- Lead Operations staff in post-study review of study-specific best practices assessment
- Contribute to the vendor selection evaluation, including the bid defense process
- Coordinate vendor performance assessment review
- Responsible for generating the study related training for the study team, study sites, business partners and vendors
- 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
- CTM delegate to lead 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
- 4+ years’ experience as a Clinical Research Associate in a biotech, pharma, or CRO setting
- 3+ years of combined field, remote and risk-based monitoring responsibilities
- 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
Stock options | Competitive salary with annual review | 401(k) matching | Annual performance-based cash bonus | Comprehensive medical benefits through Aetna | Flexible Spending Accounts | Life insurance and disability benefits | Open vacation policy / unlimited PTO | Generous paid parental leave | Commuter subsidies | Monthly catered lunches | Choice of Mac, Windows, or Linux equipment | 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.