Clinical Research Associate

COMPANY DESCRIPTION

• IPO, clinical stage biotech with lead asset in Ph 1 and potential for first-in-class mechanism
• First precision medicine approach to GI therapeutics, with platform attracting strong partners
• Global exclusive license to Cedars-Sinai's GI biobank and bioinformatics platform
• Fully capitalized with top-tier investor syndicate

Prometheus is a IPO biotechnology company pioneering a precision medicine approach to the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment and diagnosis of inflammatory bowel disease (IBD). The company's precision medicine platform, Prometheus 360, combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus is a spin out of Cedars-Sinai Medical Center and partners with the hospital system for its biospecimens, clinical data, and bioinformatics.


SUMMARY

Responsible for providing Clinical Research support for all Prometheus sponsored clinical trials. Under the direction of the Sr. Director, Clinical Operations or designee, this position will serve as the primary support for the clinical study team.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Participate and assist in design and preparation of protocols and case report forms.
• Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
• Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
• Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
• Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
• Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
• Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
• Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
• Assist with the maintenance of clinical archive and electronic files.
• Willingness to travel (up to 25%)
• Other tasks as assigned.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• BA, BS, RN, BSN or equivalent
• Basic knowledge and adherence to GCPs
• 2 years of clinical research experience in Biopharmaceutical Industry
• Strong attention to detail
• Ability to multi-task
• Unquestionable integrity and highest ethical standards
• Excellent written and verbal communication skills
• Self-motivated, assertive, and driven

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand, walk, use hands and/or fingers to grasp handle, or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

Minimal amount of travel is expected of this job; may require travel to meet with vendors.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet.

Travel up to 25% may be required.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.