PPD Life Science CRA
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PPD Life Science CRA Job – Applications Invited Online

PPD Life Science CRA Job – Applications Invited Online. BSc Life Sciences candidates can check out all of the details on a job vacancy that is available at PPD. Interested candidates with a Bachelor’s degree in life sciences are eligible to apply online at PPD for the CRA (LEVEL II) vacancy. Check out all the information below:

Job Title: CRA (LEVEL II)

Job ID: 171925

Primary Location: Mumbai IN Fulcrum – Mumbai – IN

Other Location: IN-IN-Gurgaon-New Delhi IN Gurgaon, IN-IN-Bengaluru-Bengaluru IN Valence Block

Summarized Purpose:

Performs as well as coordinates all aspects of the clinical monitoring as well as site management procedure. Conducts remote or on-site visits to assess protocol and also regulatory compliance and also manages the required documents. Manages procedures as well as standards from various sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP standards, applicable regulations and also SOPs to guarantee subjects rights, well-being as well as data reliability. Guarantees audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and also responsibilities assigned to the role

are outlined in the task matrix.

Essential Functions:

  • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site procedures failure and also corrective/preventive actions to bring the site right into compliance as well as decrease risks. Ensures data accuracy through SDR, SDV and also CRF review as applicable through on-site and also remote monitoring activities. Assess investigational product through physical inventory as well as records review. Documents observations in reports and also letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously as well as 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. Guarantees a shared responsibility with other project team members on issues/findings resolution. Investigates and also follows-up on findings as applicable.
  • Participates 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 also ICH GCP obligations, making recommendations where warranted. Performs trial closeout and also retrieval of trial materials.
  • Guarantees that required essential documents are complete as well as in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews based on project specifications.
  • Provides trial status tracking and also 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).
  • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
  • Responds to company, client as well as applicable regulatory requirements/audits/inspections.
  • Maintains & completes administrative tasks such as expense reports as well as timesheets in a timely manner.
  • Adds to the project team by aiding to prepare of project publications/tools as well as sharing ideas/suggestions with team members.
  • Adds to various other project work as well as initiatives for process improvement, as required.

Job Qualification:

Education as well as Experience:

  • Bachelor’s degree in a life sciences-related field or a Registered Nursing certification or equivalent and pertinent formal academic/ vocational qualification.
  • Previous experience that provides the knowledge, skills, as well as capabilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
  • Valid driver’s license where applicable.
  • In some cases, an equivalency, including a combination of appropriate education, training and/or directly related experience, will be taken into consideration sufficient for an individual to meet the requirements of the role.

Knowledge, Skills as well as Abilities:

  • Proven clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge as well as medical terms
  • Demonstrated capability to attain as well as maintain a working knowledge of ICH GCPs, applicable regulations and also procedural documents
  • Well-developed critical thinking skills, consisting of but not restricted to: critical mindset, in-depth investigation for appropriate root cause analysis as well as problem-solving
  • Ability to manage Risk-Based Monitoring concepts and also procedures
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Capability to maintain customer emphasis through the utilization of good listening skills, attention to detail and also the capability to perceive customers’ underlying issues
  • Good organizational and also time management skills
  • Effective interpersonal skills
  • Attention to detail
  • Ability to remain flexible and also adaptable in a wide range of scenarios
  • Ability to work in a team or independently as require
  • Good computer skills: solid knowledge of Microsoft Office and also the ability to learn appropriate software
  • Good English language as well as grammar skills
  • Good presentation skills

Working Environment:

  • PPD values the health and also wellbeing of our employees. We support as well as encourage individuals to create a healthy as well as a balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and also reasonable manner.
  • Able to work upright and also stationary for regular working hrs.
  • Able to work in non-traditional work environments.
  • Able to utilize as well as learn standard office equipment as well as technology with proficiency.
  • Able to perform successfully under pressure while prioritizing as well as handling multiple projects or activities.
  • May have exposure to potentially hazardous elements typically found in health care or lab environments.
  • This role requires independent travel up to 80%, inclusive of travelling in automobiles, aeroplanes, and also trains.

Apply Online

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