Clinical Operations Assistant

2 days ago

Bengaluru Karnataka, India Parexel Full time

**Primary Location**: India, Bengaluru

**Job ID** R0000034693

**Category** Clinical Trials

**ABOUT THIS ROLE**:
**Job Purpose**:
The role of the Clinical Operations Assistant (COA) is to maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality.
Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case.
Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact
Harmony, as appropriate.
COA is also to support all site management team members on local billable administrative tasks and assist with QC of Central files.

**Key Accountabilities**:

- Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP)
- Photocopy, print distribute and retrieval of documents, as needed
- Maintain basic quality check procedures to ensure accurate maintenance of documents
- Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only)
- Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance
- Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery)
- Payment/invoice processing including internal follow up with payment specialists in Finance
- Courier shipment of study document to the sites, vender and clients
- Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within PAREXEL

**Skills**:

- Experience working in CROs or Life Sciences industry preferred.
- Support with document collection, customization, review for clinical trials being conducted in Japan. Liaise with sites & investigators on assigned projects to facilitate conduct and delivery.
- Work closely with project management teams on all assigned tasks.
- Ensure quality and compliance in all clinical research activities.
- Ability to interact professionally within a client organization.
- Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
- Strong interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Effective time management in order to meet study needs, team objectives, and department goals.

**Knowledge and Experience**:

- Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

**Education**:

- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

  • Clinical Operations Manager

    7 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job SummaryThe Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure...

  • Clinical Operations Manager

    7 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job SummaryThe Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure...

  • Clinical Operations Manager

    7 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job SummaryThe Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure...

  • Clinical Operations Manager

    7 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Summary The Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure...

  • Clinical Operations Manager

    7 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Summary The Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure...

  • Clinical Operations Manager

    6 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job SummaryThe Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure...

  • Clinical Operations Manager

    5 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job SummaryThe Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure...

  • Clinical Operations Manager

    2 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Summary The Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure...

  • Clinical Research Coordinator

    1 week ago

    Domlur, Bengaluru, Karnataka, India MS CLINICAL Full time

    **Job Title**: Clinical Research Coordinator (minimum 1 year of experience)** **Company**: MS Clinical Research Pvt Ltd** **About Us**: MS Clinical Research (MSCR) is a dynamic and forward-thinking clinical research organization dedicated to conducting cutting-edge clinical trials. We are committed to advancing medical science and contributing to the...

  • Clinical Investigator- Clinical Operations Ba/be

    2 weeks ago

    Bengaluru, Karnataka, India Apotex Research Private Limited Full time

    **About Apotex Inc.** **Job Summary**: Handle and administer the BE studies or clinical trial in Bioequivalence center, India also managing the screening and in study assessment and medical care of clinical volunteers. **Responsibilities**: - Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center’s Standard Operating...