{"id":3732054,"url":"https://alion.io/job/lifelancer-cra-level-ii","title":"CRA (Level II)","company":{"id":3853997,"name":"Lifelancer","domain":"lifelancer.com","url":"https://alion.io/company/lifelancer","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":true,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["IN"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-01T12:36:12Z","employer_posted_date":null,"last_verified_at":"2026-11-01T12:36:12Z","board_verified":false,"closed_at":null,"days_open":6,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":6},"description":"Job Title: CRA (Level II)\nJob Location: Remote, India\nJob Location Type: Remote\nJob Contract Type: Full-time\nJob Seniority Level: Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJoin Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.\n\nDESCRIPTIONAs part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments. Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.\n\nWhat You'll Do:\nMonitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.\n\nParticipates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.\n\nEnsures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.\n\nProvides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).\n\nFacilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.\n\nResponds to company, client and applicable regulatory requirements/audits/inspections.\n\nMaintains & completes administrative tasks such as expense reports and timesheets in a timely manner.\n\nContributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.\n\nContributes to other project work and initiatives for process improvement, as required.\n\nREQUIREMENTSEducation and Experience Requirements:\nBachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.\n\nPrevious experience that provides the knowledge, skills, and abilities to perform the job (including at least 2 years on-site monitoring experience)\n\nBased in Metro city location - Mumbai, Delhi, Hyderabad, Bengaluru, Pune\n\nKnowledge, Skills and Abilities:\nProven clinical monitoring skills\n\nDemonstrated understanding of medical/therapeutic area knowledge and medical terminology\n\nDemonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents\n\nWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving\n\nAbility to manage Risk Based Monitoring concepts and processes\n\nGood oral and written communication skills, with the ability to communicate effectively with medical personnel\n\nAbility to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues\n\nGood organizational and time management skills\n\nEffective interpersonal skills\n\nAttention to detail\n\nAbility to remain flexible and adaptable in a wide range of scenarios\n\nAbility to work in a team or independently as required\n\nGood computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software\n\nGood English language and grammar skills\n\nGood presentation skills\n\nWorking Conditions and Environment:\nWork is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.\n\nFrequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.\n\nExposure to biological fluids with potential exposure to infectious organisms.\n\nPersonal protective equipment required such as protective eyewear, garments and gloves.\n\nExposure to fluctuating and/or extreme temperatures on rare occasions\n\nThis job is curated by Lifelancer.Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.\nPlease apply via Lifelancer platform to get connected to the application page and to find similar roles.\nOriginally posted on Himalayas","description_format":"text","description_chars":6514,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Home office"],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Internet Services","CRO & CDMO Services","Healthcare Staffing"],"lifecycle":[{"event":"open","at":"2026-11-04T08:28:30Z"}],"visa":[],"liveness":{"score":54,"band":"ok","label":"Likely open","p_open":1,"p_active":0.542,"p_room":1,"age_days":5,"expected_fill_days":28,"reasons":["seen:5","agency","velocity","win:early","comp:brand"],"computed_at":"2026-11-07T05:47:08Z"},"pay":null,"html_url":"https://alion.io/job/lifelancer-cra-level-ii","json_url":"https://alion.io/job/lifelancer-cra-level-ii.json","meta":{"generated_at":"2026-11-08T02:44:23Z","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":5840,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"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":3853997},"rest":"https://alion.io/mcp/rest/get_company?id=3853997"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flifelancer-cra-level-ii"},{"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%2Flifelancer-cra-level-ii"},{"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%2Flifelancer-cra-level-ii"},{"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/lifelancer-cra-level-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flifelancer-cra-level-ii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3732054}},{"tool":"search_jobs","arguments":{"company":"lifelancer.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3732054},"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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