JOB TITLE: Clinical Development AssociateLOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, WI, MS or WA.
REPORTS TO: Director, Clinical Science
SALARY RANGE:$92,000 to $120,000The Clinical Development Associate will support the clinical development team with day-to-day clinical trial execution, including data and safety review, safety and efficacy metric tracking, and internal and external cross-functional collaboration to help advance Aurion Biotech's clinical programs.
KEY RESPONSIBILITIES- Support the clinical development team with ongoing scientific and medical oversight and support throughout study startup, enrollment, conduct, database lock, and study closeout
- Support Medical Monitoring activities and contribute to patient cleaning activities, including assisting with medical monitor query management
- Identify clinical risks and proactively help develop mitigation strategies
- Support the clinical scientist with development of study protocols, protocol amendments, informed consent documents, case report forms, and other clinical study documents
- Collaborate with the clinical scientist to help address protocol questions, eligibility determinations, deviations, and study conduct challenges
- Ensure clinical studies are conducted in accordance with protocol requirements, ICH-GCP, applicable regulations, and Aurion SOPs
- Partner with Biometrics and/or Data Management to help develop data review plans and ensure data quality
- Support ongoing review of clinical, efficacy, safety, imaging, and biomarker/pharmacokinetic data
- Assist members of clinical development with contribution to regulatory meeting preparation and interactions with global health authorities, as assigned
- Support preparation of briefing documents, responses to agency questions, and submission documents, as assigned
- Assist with the contribution of scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications
- Partner closely with Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality Assurance, and external 3rd party vendors including CRO partners and imaging centers
- Support inspection readiness activities and participate in audits and regulatory inspections
- Contribute to continuous process improvement initiatives within Clinical Development
- Support a collaborative, high-performance culture aligned with Aurion's mission and values
QUALIFICATIONS AND EDUCATIONTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- A strong background in ophthalmology, ophthalmology clinical trials, and interpretation of ophthalmology data including visual acuity procedures and image collection
- Bachelor's degree in life sciences, nursing, or related field preferred
- 1-3 years of experience in clinical research, including exposure to clinical trial operations, either in a sponsor, CRO, or academic setting supporting Phase 2 or 3 clinical trials.
- Familiarity with study start-up, site maintenance, closeout, and inspection readiness processes.
- Working knowledge of ICH/GCP guidelines and clinical trial processes.
- Strong organizational and time management skills; detail-oriented and able to manage multiple tasks.
- Proficient in Microsoft Office (Word, Excel, PowerPoint); experience with TMF, EDC, and other clinical trial systems a plus.
- Strong interpersonal and communication skills, both written and verbal.
REQUIRED SKILLS AND ABILITIES- Ability to work effectively in a team environment and across global teams and vendors
- Excellent written, verbal, and interpersonal communication skills; ability to communicate with impact across diverse internal and external stakeholders.
- Demonstrated cultural agility, integrity, and a passion for advancing transformative science.
- Ability to travel up to 15%, candidates local to an office may be asked to periodically travel to the office for meetings or clinical operations department support
- A strong alignment with, and commitment to, Aurion Biotech's mission, vision, and core values.
Salary Description
$92,000 to $120,000
