Senior Clinical Research Associates, East Coast (Eastern time zone) and West Region (Pacific or Mountain time zone)(2 vacancies)
Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Research Associates for coverage on the East Coast (Eastern time zone) and West Region (Pacific or Mountain time zone)(2 vacancies). The incumbents may be required to travel to other locations across USA respectively to support monitoring activities as necessary.
The incumbent will monitors, reports, tracks study progress, and assesses compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures (SOPs). The role may include leadership of the Clinical Operations study team as well as assessment and direction of other Clinical Operations staff assigned to studies.
- Interact with personnel from study sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high quality initiations and completions of clinical trials.
- Identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.
- Compile documentation for qualification of clinical sites. Review that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
- Assist with preparation and submission of regulatory documents to responsible authorities and IRB/ECs.
- Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in Trial Master Files. These files must be maintained in a fashion so that they are continuously available for audit and completion for archive.
- Contribute to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include Monitoring Plans, Risk Management Plans, study guides or manuals, and information collection tools.
- Develop and review documentation of information provided to study subjects, including informed consent forms.
- Assist with the preparation and negotiation of contracts with vendors and investigational sites.
- Participate in and prepare presentations for clinical trial initiation meetings such as investigator meetings or site monitor/coordinator training sessions. Address questions/concerns relevant to Clinical Operations from the meeting participants. Train Clinical Research Associates and site personnel on study requirements and procedures.
- Perform on-site monitoring of clinical studies.
- Document monitoring activities through submission of monitoring reports to Clinical Operations management for review, and through correspondence and telephone contact with investigative sites.
- Responsible for site management. Communicate directly with sites to provide direction, to assess performance, and to propose interventions to enhance enrollment performance.
- Monitor and report progress/status of investigational sites.
- Assist with investigator payments.
- Provide timely and accurate reports of travel expenses.
- Assist in the preparation, planning, and presentation of bid defenses.
- Participate in the development and maintenance of, and adhere to departmental SOPs and guidelines.
- Prepare, maintain, and complete training on study-specific and (or) applicable sponsor SOPs.
- Support sites in their efforts to prepare for audits conducted either by sponsors or regulatory authorities.
- Plan and carry out professional development.
Qualifications and Experience:
- Bachelor’s degree in a life science or related field of study.
- Five years field monitoring clinical trials.
- Thorough knowledge of GCPs.
- Thorough comprehension of medical terminology.
- Excellent command of verbal and written English.
- Ability to travel a maximum of 70% of working hours is required.
How to Apply:
Please send your application along with cover letter to [email protected]
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com.
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.