Reports to: Sr. Director Clinical or designee
The role of the Senior Clinical Research Associate (CRA) is to support several ongoing and upcoming clinical trials (Phase 1b through Phase 3). The position will monitor patient recruitment, enrollment, data and study-related information related to clinical trial sites and study participation. Ensures the investigators adhere to the established clinical protocols, regulatory requirements and Good Clinical Practice, and provides input into data validation. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. Travel to clinical sites will be necessary.
This is a senior-level position in the Clinical Operations track. The candidate must have extensive experience as a senior CRA including the ability to interact effectively with investigators and cross-functional teams. Leadership skills and participation in a management team are key aspects of the position. He or she possesses medical and technical aptitude and can demonstrate comprehensive and current knowledge in relevant therapeutic or product areas and possess an excellent command of medical and scientific areas assigned.
- Ensures timely and accurate study-related communication to internal and external study team (including CRO and site personnel): assists in preparation, distribution and tracking (as needed) of clinical trial correspondence, newsletters, and IND Safety Letters, and assists with the creation of study-specific protocols, manuals, tools, and templates. Prepares case report forms and ensures conformance to clinical protocol, GCP and guidelines. Writes/reviews Clinical Study Reports.
- Coordinates specified periodic clinical trial meetings (e.g., investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, managing preparation of necessary materials, training clinical site personnel on study procedures, and being responsible for recording and distributing minutes.
- Assists with site feasibility, qualification and selection process; conducts site monitoring visits, manages study monitoring schedule, audits CRFs for conformity to source documentation, and conducts study close-out visits. Sets target timelines and oversees adherence to timelines. Ensure team members compete action items in a timely manner.
- Maintains audit-ready clinical trial documentation and study status: manages and tracks regulatory documentation, IND Safety Letter distribution, Confidentiality Agreements and Clinical Trial Contracts, as well as other clinical trial documents.
- Ensures that necessary study supplies are available at sites as necessary, coordinating with appropriate vendors as needed: (i.e., Case Report Forms, Study Manuals, lab kits, drug supplies, lab supplies, etc.); manages review and tracking drug shipment, destruction/return.
- Manages clinical operations site payment system, prepares site invoices and supporting documentation and initiates/creates clinical/regulatory department Purchase Orders.
- Assists in review and tracking of vendor reports, budgets, and metrics.
- Manages and helps create clinical trial tracking metrics and reporting for internal and external collaborators.
- Mentoring, training, performance management, and career development for direct reports and clinical team.
- Participates in selection and management/oversight of external vendors and assists in developments of vendor specifications.
- Coordination, tracking and managing quality control, vendor or Sound Pharmaceuticals utilization and shipping of clinical site laboratory samples.
Education and Experience:
- Bachelor’s degree (life sciences preferred), or equivalent; or a LVN, RN, PA, Audiology (desirable) or other licensed health care professional degree.
- Minimum 5 years of experience directly supporting clinical research trials or similar experience in a medical/scientific area.
- 3-5 years of experience managing projects, working with clinical professionals within a team, and working in a cross-functional product development setting. IND/NDA/BLA filing experience preferred.
- Experience with electronic data capture preferred; experience with eCTD filing preferred.
- Human Subjects Research certification is required.
- Clinical Research Associate certification and/or Good Clinical Practice training certification desirable.
- Professional use of the English language, both written and oral, is required.
Physical Demands and Work Environment:
- Out of area travel may be required (up to 50%)
- Performs general office environment duties
- May occasionally lift up to 30 pounds
- Vision requirements include close and focusing ability
- Noise level is moderate
Interested candidates are encouraged to apply by sending a resume and a cover letter to info@SoundPharma.com for consideration. Sound Pharmaceuticals, Inc. is an equal opportunity employer and supports diversity in the workplace.