Clinical Research Cordinator

2 weeks ago

Remote, India IQVIA Full time

Job Overview
Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.

Essential Functions
- Provide clinical research support to investigators to prepare for and execute assigned research studies, including:

- Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data;
- Attend all relevant study meetings;
- Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research;
- Design and maintain source documentation based on protocol requirements;
- Schedule and execute study visits and perform study procedures;
- Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics;
- Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards;
- Assist with study data quality checking and query resolution.
- Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
- Record, report and interpret study findings appropriately to develop a study-specific database.
- Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
- Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
- Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
- Assist research site with coverage planning related to staffing and scheduling for research projects.

Qualifications
- Bachelor's Degree Req Or
- High School Diploma or equivalent Req
- 3 years’ relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience Req
- Working knowledge of clinical trials
- Working knowledge of the principles of Good Clinical Practices (GCP)
- In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing
- Excellent interpersonal skills
- Ability to pay close attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies Req

  • Clinical Research Trainer

    2 weeks ago

    Remote, India Clariwell Global Services Full time

    Relevant experience includes a minimum of 2+ years of clinical trials coordination and/or management experience. knowledge of FDA and other regulatory guidelines (e.g., ICH-GCP E6, HIPAA) that govern clinical research. A minimum of 2+ years of experience as a trainer, teacher, or instructor in clinical research, another medical field, or life sciences, OR...

  • Clinical Research Associate

    1 week ago

    Remote, India NexPro Technologies Inc Full time

    Position Summary The Clinical Research Associate II (CRA II) will be a key contributor to AtriCure’s clinical affairs department and primarily responsible for the site management of assigned clinical investigative sites.The CRA II will assist with the implementation and execution of study protocols and associated study documents for clinical trials,...

  • Clinical Research Associate

    2 weeks ago

    Remote, India Synergy Physicians Full time ₹ 52,000 per year

    Job Title: Clinical Research Associate (Remote – MBBS/PhD Students)Company: Synergy Health 360 – Research DepartmentLocation: Remote (India-based applicants, U.S. time zone / India night shift)About Us:Synergy Health 360 is an innovative and expanding healthcare organization based in Arizona, USA. Our mission is to enhance patient outcomes while creating...

  • Clinical Research Associate 2

    2 weeks ago

    Remote, India ICON Full time

    Primary point of contact between site staff and NN. Acts as ambassador for the company and contributes to making NN the preferred partner. Responsible for managing the site to meet patient recruitment rate and target. Delivers results that have direct impact on the successful completion of the clinical program. Coordinates with PM and communicates to them...

  • Clinical Research Associate

    3 days ago

    Remote, India ICON Full time

    As a (job title) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - In general, a CRA would manage 12 sites but this could vary at individual assignment level considering the trial stage and complexity. Trial assignment will be performed by the...

  • Research Coordinator

    1 week ago

    Remote, India yogis ayurveda Full time ₹ 38,448 - ₹ 5,28,647 per year

    JOB DUTIES RESEARCH CO-ORDINATOR· Protocol development: Collaborate with principal investigators (PIs) and other researchers to design and write trial protocols and supporting documents for clinical studies.· Study setup: Create and organize study files, case report forms (CRFs), and other materials required for the research.· Regulatory submissions:...

  • Clinical Trial Psych Rater

    2 weeks ago

    Remote, India IQVIA Full time ₹ 14,40,000 - ₹ 36,00,000 per year

    Clinical Specialist Consultant - Malayalam SpeakingLocation:Remote/virtualHours:Estimated 10-16h/monthRole:Clinical SpecialistJob Description:The Clinical Specialist reviews scales administered by raters in a clinical trial to ensure that assessments are being conducted in a standardized manner to ensure data reliability. The quality of assessments is...

  • Medical Writer I

    2 weeks ago

    Remote, India Syneos Health Clinical Full time

    **Description** **Medical Writer I (R**edaction/Clinical Trial Transparency)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...

  • Clinical Intern

    3 days ago

    Remote, India Ihealthmantra Full time ₹ 2,88,000 per year

    Position: Clinical InternCompany: Rxoom Healthcare Pvt. Ltd.Department: Application Support & Marketing.Job Description:Rxoom Healthcare Pvt. Ltd., a leading OEM of Neuronavigation Systems, is looking for passionate and enthusiastic interns from a Biotechnology background to support clinical and product application activities. The role offers hands-on...

  • Medical Writer Ii(Plain Language Summary

    3 days ago

    Remote, India Syneos Health Clinical Full time

    **Description** **Medical Writer II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...