Hyderabad Telangana Plan manager Jobs – 2329 Open Jobs Today

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Clinical Research Associate - II

AXIS Clinicals -
Miyapur, Hyderabad, Telangana

Apply Now

Job details

Full-time

Qualifications

Clinical research
English
Master's degree
Quality assurance
Presentation skills
Bachelor's degree
Clinical trials
Communication skills
Negotiation

Full job description

Job Description

Essential Function:

The responsibility of a CRA II is to perform all clinical monitoring/ site management activities for assigned projects in accordance with AXIS SOPs

A CRA is responsible for achieving and maintaining high site performance, managing clinical monitoring activities which include the ownership of investigator sites, the selection of investigator/sites, collating regulatory documentation, initiating and monitoring of sites, performing site documentation verification, data collection and drug accountability in accordance with applicable guidelines and regulations.

If applicable, a CRA III may also act as co-Clinical Lead

Relationships:

Reports to: Clinical Lead (CL), Project Manager (PM)

Directly supervises: None

Provides work direction to: None

Works closely with: Project Managers, Clinical Logistics, Data Manager, Quality Assurance, Business Operations, Finance

External relationships: Subcontractors

Responsibilities:

Site Feasibility: Contacts potential investigators to discusses the study details providing critical information needed to obtain the desired feedback to the assess the feasibility of the proposed study
Site Management Activities: Prepare and submit or support those involved in regulatory and ethics committee submissions Ensure that documents are collected in a timely manner in order to meet regulatory and ethics committee/IRB submission dates
Initiate, monitor and close out investigational sites
Attend staff meetings and training sessions as required to complete the training curriculum in a timely manner
Assist with the audit of a site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP guidelines.
Build and maintain good and effective relationships with sites
Ensure the timely and accurate investigator payments
Provide training and assistance to more junior clinical staff
Clinical Monitoring Activities:
Assist with the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures
Ensure that the site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines
Ensure that the site personnel are adhering to the protocol and address any issues concerning protocol non-compliance with the principal investigator
Provide ongoing training to the site personnel with regards to applicable guidelines and AXIS SOPs to ensure the quality and integrity of the data
Ensure the effective and timely co-ordination of the supply (and subsequent disposal) of clinical materials to the site to ensure that the site can start to actively recruit patients as soon as ethical approval at the site has been granted
Collaborate with other departments (e.g. Medical/ Pharmacovigilance, Regulatory) to ensure that the principal investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities within the specified time periods
o Perform site visits to ensure that the site personnel conduct the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. Any concerns or ongoing issues should be escalated to the CL, Team Leader, Project Manager as appropriate
Prepare and submit visit reports in a timely manner (Per AXIS SOPs or contract as appropriate)
Interact with investigators to obtain necessary documentation and information before, during and after the study. Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete, meet quality requirements and can be used as a source of reference
Perform ongoing on site data management/collection to ensure that issues relating to the quality of the data are communicated to the site personnel early and maintain close contact with Data Management.
Maintain project tracking system (CTMS or client equivalent, Patient Recruitment Plan, etc.) on an ongoing basis to ensure that progress regarding the sites can be tracked. Provide status updates to the Project Manager, CL and client as required
Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

Skills

Excellent interpersonal, site management and relationship building, verbal and written communication skills including presentation skills
Team player with outstanding negotiation and organizational skills
Client focused approach to work
A flexible attitude with respect to work assignments, new learning and travel (overnight, weekend and occasional international travel may be required)
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of team work
IT literate (experience with Microsoft based applications and general knowledge of PC functions)
Able to take initiative and work independently (with little help)
Sense of urgency in completing assigned tasks

Education:

Educated to Bachelor’s or Master’s degree level (biological/ life science, pharmacy or other health related discipline preferred)

Language Skills:

Competent in written and oral English

Minimum Relevant Work Experience:

 3+ years of on-site clinical trial monitoring experience with a pharmaceutical, CRO, or device company

Physical Requirements:

 Ability to travel an average of 50% (project driven)

Job Snapshot

Updated Date

21-02-2022

Job ID

CRA II_02

Department

Clinical Research

Location

Miyapur, Hyderabad, Telangana, India

Experience

2 - 4 Years

Employee Type

Full Time - 30

Apply Now

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