Senior Clinical Research Associate
2 months ago
When our values align, there's no limit to what we can achieve.
The Early Clinical Development Senior Clinical Research Associate will have relevant Phase I experience, responsible for conducting monitoring activities for one or more client sponsored studies. The Sr. CRA functions as a member of the clinical study team and performs study monitoring according to Good Clinical Practices (GCP), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and client Standard Operating Procedures (SOPs).
• Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs
• Responsible for monitoring clinical trial quality and site management for client sponsored studies that are not fully outsourced to a contract research organization (CRO)
• Conducts site qualification, initiation, interim, and close-out visits
• Ensures sites meet performance expectations related to recruitment, enrollment, and retention
• Reviews site source documentation, case reports, and verifies accurate data capture
• Ensures site regulatory files are current, and verifies the timely submission of study documentation (including safety reporting)
• Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol
• Identifies and records protocol deviations
Site Management
• Maintains ongoing communications with site personnel and assists with problem solving during all stages of study start up, conduct, and close out
• Builds and maintains professional relationships with site personnel
• Analyzes issues and uses sound judgment to make decisions and escalates study related issues as necessary
• Travels to clinical study sites as required, including remote or onsite visits globally
Skills:
• Analytical problem-solving experience, trouble shooting and resourcefulness
• Working knowledge of clinical drug development process
• Effective communication, interpersonal skills, and the ability to build relationships
• Familiarity with medical and clinical trial terminology
• Proficient in written and spoken English required
• Proficient in local language, as applicable, preferred
• Proficiency in widely used technologies
• Ability to learn client applications
• Travel to be inclusive of regional, national and international as required
Knowledge and Experience:
• Minimum of 5 years relevant industry experience
Education:
• Bachelor’s Degree or equivalent is required
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
-
Senior Clinical Research Associate
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeParexel Career OpportunitiesThe Early Clinical Development Senior Clinical Research Associate will have relevant Phase I experience, responsible for conducting monitoring activities for one or more client sponsored studies.Key Responsibilities:Perform site management activities to ensure compliance to the protocol, monitoring plan, Good Clinical Practices...
-
Clinical Research Coordinator
6 months ago
Nagpur, India Fusion Market Research Full time_**Duties/Responsibilities**:_ - Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators...
-
Clinical Development Expert
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeJob SummaryParexel is seeking an experienced Clinical Development Expert to join our team as a Senior Clinical Research Associate. This role offers the opportunity to work on exciting projects, collaborate with talented professionals, and contribute to the development of innovative treatments.About the JobWe are looking for a highly motivated individual with...
-
Project Leadership
6 months ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, helping to...
-
Biotech Project Leadership
5 months ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while...
-
Project Leadership – Biotech
3 months ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while...
-
Manager, Clinical Operations
1 month ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Parexel is G-R-O-W-I-N-G and has exciting opportunities to join our Clinical Operations Leader team. We currently have home-based Manager, Clinical Operations Leaders positions that can be located in the US or Canada. The Manager, Clinical Operations Leaders is responsible for their...
-
Clinical Project Manager
4 weeks ago
Nagpur, Maharashtra, India Parexel Full timeJob OverviewParexel is seeking an experienced Clinical Project Manager to lead our Biotech division. This role will be responsible for managing global clinical trials, collaborating with cross-functional teams, and delivering projects on time, within budget, and to the highest quality.About UsParexel is a leading Contract Research Organization (CRO) that...
-
Associate/Medical Director
5 months ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Parexel is known for our unparalleled expertise in Dermatology! Over the past five years Parexel has provided clinical research services for ~100 dermatology studies, enrolling more than 20,000 patients at ~5,000 hospitals and clinics worldwide We play an integral role in bringing new...
-
Project Lead for Global Clinical Trials
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeAbout ParexelParexel is a leading global clinical research organization that partners with biopharmaceutical and medical device companies to accelerate the development of innovative treatments. Our team shares a common goal: to deliver high-quality results on time, within budget, and with exceptional client satisfaction.About the JobWe are seeking an...
-
Vice President, Technical
6 months ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. As one of our ex-FDA colleagues describes it: “you get to see a lot of cool stuff very quickly”. If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as a Vice President,...
-
Clinical Research Associate
4 months ago
Nagpur, Maharashtra, India Clariwell Global Services Full timeCreating and writing trial protocols, and presenting these to the steering committee. - Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial. - Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion. - Ordering, tracking, and managing IP...
-
Senior Quality Assurance Specialist
1 month ago
Nagpur, Maharashtra, India Parexel Full timeAbout the Role:Parexel seeks a seasoned Senior Quality Assurance Auditor to join our team of dedicated professionals driving excellence in clinical research.Key Responsibilities:Lead, perform, and report audits for area of specialization, working closely with internal customers to develop and execute strategic audit plans.Manage GxP audits, ensuring...
-
Senior Desktop Engineer
1 month ago
Nagpur, Maharashtra, India Parexel Full timeParexel: A Leader in Clinical Research OrganizationWe are a leading Clinical Research Organization company delivering life-changing medicines to patients. Our team is seeking a Senior Desktop Engineer – EUC to contribute to the ongoing development of technology solutions related to end user computing.Key Responsibilities:Provide escalated technical support...
-
Senior Quality Assurance Auditor
6 months ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Join Parexel’s team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to...
-
Senior Biopharma Strategy Expert
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeParexel, a leading global biopharmaceutical solutions organization, is seeking an experienced Senior Biopharma Strategy Expert to join our Regulatory Strategy team.About the RoleWe are looking for a highly skilled and accomplished professional with extensive experience in clinical development, clinical trial design, and regulatory affairs. The ideal...
-
Medical Coding
6 months ago
Nagpur, Maharashtra, India Fusion Market Research Full time.**Responsibilities for Medical Coder** - Assign codes to diagnoses and procedures, using ICD (International Classification of Diseases) and CPT (Current Procedural Terminology) codes - Ensure codes are accurate and sequenced correctly in accordance with government and insurance regulations - Follow up with the provider on any documentation that is...
-
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Our Global Medical Services (GMS) organizational model/structure is aligned around key therapeutic franchises (5 franchises and 20 + Therapeutic Areas) to support high quality medical monitoring, leverage our expertise, strengthen, and build our customer relationships and drive new...
-
Senior Technology Quality Assurance Auditor
1 month ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Home Based, US As a Senior Technology Quality Auditor (TQA) you will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of internal and supplier technology audits. You will exhibit a high degree of flexibility and...
-
Investment Banking Associate
5 days ago
Nagpur, India Intellectual Capital HR Consulting Pvt. Ltd. Full timeJob Overview:We are seeking a highly motivated and skilled Investment Banking Associate to join our dynamic team. The associate will play a key role in supporting the execution of M&A transactions, capital raises, and other investment banking services. This role requires strong analytical skills, attention to detail, and the ability to work under tight...