{"id":2170782,"url":"https://alion.io/job/parexel-senior-initiation-clinical-research-associate","title":"Senior Initiation Clinical Research Associate","company":{"id":2735,"name":"Parexel","domain":"parexel.com","url":"https://alion.io/company/parexel","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":43,"ghost_share":0,"stale_share":0.884,"repost_share":0,"time_to_fill_p50_days":17,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":16500,"max_usd":38000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1296},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-07T00:00:00Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-11-05T13:17:42Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"When our values align, there's no limit to what we can achieve.\nAt Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.\nEach of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.\nAbout Parexel\nParexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.\nWe work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.\nAbout the Role\nWe are seeking an Initiation Clinical Research Associate (iCRA) specializing in Pre-SIV and Activation tasks to join our team in India-Bengaluru capacity on a hybrid / on-site basis. As an iCRA, you will drive the strategy and execution of study startup, Pre-SIV, and activation activities while serving as Parexel's primary point of contact with assigned clinical sites. This position plays a critical role in ensuring regulatory compliance, maintaining trial master file quality, and supporting site readiness for successful study initiation.\nYou'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic site management, regulatory excellence, and collaborative problem-solving. With diverse teams and continuous learning opportunities, the iCRA role offers pathways to deepen expertise in clinical trial operations and expand skills across regulatory, compliance, and study execution functions.\nKey Responsibilities\nAct as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the startup phase, including building relationships with investigators and site staff.\nSupport country-specific feasibility and site qualification activities, including preparation, negotiation, and facilitation of Confidentiality Agreements (CDAs) and Qualification Visits (QVs).\nManage country and site-level Trial Master File (TMF) issues, ensuring First Time Quality (FTQ) documentation and providing direct resolution to reported site problems.\nDevelop and execute strategy for configuring, distributing, collecting, and reviewing high-quality country-specific and site-specific regulatory documents, including Site SIV Readiness documentation.\nCustomize, review, and negotiate country/site-specific Informed Consent Forms (ICFs), translations, and amendments within regulatory parameters.\nPrepare and submit IRB/IEC and MoH/RA applications, resolving conflicts and determining appropriate follow-up until receipt of final approval.\nUpdate and maintain the Clinical Trial Management System (CTMS) in a timely manner with accurate startup and amendment information.\nPromptly identify, address, and resolve site questions and issues, including potential risks to activation timelines, recruitment strategy challenges, training deficiencies, and compliance concerns.\nFacilitate site access to relevant study systems and ensure compliance with all project-specific training requirements prior to study initiation.\nActively participate in internal and external meetings as needed and maintain audit and inspection readiness at assigned sites.\nWork independently with limited oversight, proactively communicating progress, risks, and issues to management.\nYou'll thrive in this role if you bring:\nStrong problem-solving skills and the ability to work independently while proactively seeking guidance when necessary.\nFlexibility and willingness to learn, with the ability to prioritize multiple tasks and make autonomous decisions in a fast-paced environment.\nComfort working in a matrix environment with strong collaboration and teamwork skills.\nA patient-focused mindset with strong attention to detail and commitment to high-quality, compliant work.\nStrong computer skills, including proficiency with Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), and Microsoft Office products.\nRequired Qualifications\nDegree-level education in biological science, pharmacy, or other health-related discipline, or equivalent nursing qualification or equivalent experience.\nSubstantial startup experience or equivalent experience in clinical research, with demonstrated understanding of clinical trial methodology and terminology.\nKnowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.\nExperience with Clinical Trial Management Systems (CTMS) and Electronic Trial Master Files (eTMF).\nStrong communication, organization, and problem-solving skills with the ability to manage multiple priorities.\nPreferred Qualifications\nExperience in regulatory affairs or site management functions.\nFamiliarity with international regulatory requirements and multi-country study operations.\nExperience with study initiation or site activation processes.\nWe believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.\nIf this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!","description_format":"text","description_chars":5927,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Continuous learning"],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-09T11:54:58Z"}],"visa":[],"liveness":{"score":25,"band":"fade","label":"Fading","p_open":1,"p_active":0.559,"p_room":0.45,"age_days":29,"expected_fill_days":17,"reasons":["conf:4","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/parexel-senior-initiation-clinical-research-associate","json_url":"https://alion.io/job/parexel-senior-initiation-clinical-research-associate.json","meta":{"generated_at":"2026-11-05T14:52:20Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":19322,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2735},"rest":"https://alion.io/mcp/rest/get_company?id=2735"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fparexel-senior-initiation-clinical-research-associate"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fparexel-senior-initiation-clinical-research-associate"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fparexel-senior-initiation-clinical-research-associate"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/parexel-senior-initiation-clinical-research-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fparexel-senior-initiation-clinical-research-associate"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2170782}},{"tool":"search_jobs","arguments":{"company":"parexel.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2170782},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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