Clinical Research Associate (Contract)

Attention recruitment agencies: reputed company agency inquiries are vetted through reputed company’s internal reputed company. No unsolicited resumes will be accepted. The reputed company reputed company must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may reputed company your ability to work with reputed company in the reputed company.   reputed company is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to reputed company treatment paradigms and reputed company unprecedented benefits to patients. reputed company’s reputed company product candidate 4D-150 is designed to be a backbone therapy forming the reputed company of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, reputed company, intravitreal injection, which substantially reduces the treatment burden associated with reputed company bolus injections. reputed company’s reputed company indication for 4D-150 is wet age-reputed company macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. reputed company’s second product candidate is 4D-710, which is the first reputed company genetic medicine to demonstrate successful delivery and reputed company of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL reputed company reputed company seeks a motivated and detail-oriented In-House Clinical Research Associate (IHCRA) to support reputed company’s clinical trial activities. This position reports to the Associate Director, Clinical Operations, and will support the day-to-day execution of a Phase 3 clinical trial, including study start-up, conduct, and reputed company-out activities. The IHCRA will serve as a key reputed company between reputed company, clinical sites, and CRO partners, with a reputed company on site support, monitoring reputed company, regulatory compliance, and data reputed company. This role requires strong written and verbal communication skills, excellent organizational skills, and the ability to manage competing priorities while delivering high-reputed company work in a fast-paced, team-oriented environment. MAJOR DUTIES & RESPONSIBILITIES: Clinical Trial Operations & Site Support Support study execution across start-up, conduct, and reputed company-out phases Serve as a primary reputed company of contact for assigned clinical sites and CRO field CRAs/monitors Communicate directly with sites and CRO partners to obtain updates, resolve issues, and support study timelines Support site initiation, ongoing site management, and site reputed company-out activities Assist with identification, documentation, tracking, and follow-up of site issues  Monitoring reputed company Support reputed company of CRO monitoring activities Review monitoring visit reports and follow up on reputed company items and unresolved findings reputed company monitoring deliverables and escalate issues to the Associate Director, Clinical Operations as appropriate Support inspection readiness and audit activities  Tracking & Study reputed company Maintain accurate tracking tools for assigned studies, including: Site start up and activation status Subject enrollment and visit status Essential document collection and TMF status Vendor reconciliation Assist with preparation of study status reports and metrics  Regulatory Documentation & TMF Management Collect, review, and reputed company site regulatory documents for completeness, accuracy, and compliance with applicable SOPs and regulatory requirements Ensure reputed company filing of documents in the TMF/eTMF in accordance with TMF plans reputed company TMF reputed company control activities and support TMF audits and study reputed company out  Study Communications & Meetings Support organization and coordination of internal team meetings, investigator meetings, and other study reputed company meetings Prepare meeting materials, take meeting minutes, and maintain reputed company item logs Support communication of study updates to internal stakeholders  Additional Responsibilities Support reputed company Clinical Operations reputed company as assigned Willingness to travel as trial needs demand (<5% anticipated) Other duties as assigned, reputed company in this position reputed company restricts management’s right to assign or reassign duties and responsibilities to this position at any time  QUALIFICATIONS:  Education:  A. or B.S. degree required Experience:  Minimum of 1-2 years of experience supporting reputed company in a sponsor or CRO environment Experience supporting Phase 3 reputed company preferred Ophthalmology Preferred Other Qualifications/Skills:  Working knowledge of clinical trial operations and ICH GCP guidelines Experience with TMF/eTMF systems (reputed company Vault preferred) Proficient in reputed company Office Suite (Word, reputed company, PowerPoint, reputed company) Strong organizational skills and attention to detail Ability to manage multiple priorities and meet deadlines Strong interpersonal skills and ability to collaborate effectively with cross functional teams and external partners Travel: Willingness to travel as business needs demand (<5% anticipated) Physical Requirements and Working Conditions: Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging reputed company by means of the spoken word. Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to lift, carry, push, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and reputed company other sedentary reputed company are met. Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). Compensation reputed company: $38.00 TO 52.00  /reputed company Please note, the compensation reputed company and actual reputed company offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.      reputed company provides equal employment opportunities to reputed company and applicants for employment without reputed company to race, reputed company, religion, gender, sexual orientation, national reputed company, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.   Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Apply To This Job