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Principal Investigator

  • LocationWaterbury, CT 06708 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:6 days ago
  • Job no: 39122
  • Category: R&D

Job Description

We are seeking a driven individual with a passion for the clinical research industry. One of our clients is looking to add a strong Principal Investigator to their team. Responsibilities include:

1) Work with the Medical Director, principal investigators, sub-investigators and physicians

2) Provide investigator qualifications and agreements by maintaining a current and up-to-date resume

3) Maintain current licensure to practice

4) Provide the sponsor and IRB with documentation of credentials, as requested

5) Demonstrate the proper education, training and experience to conduct the clinical trial investigation

6) Ensure the initial and ongoing review by a duly constituted IRB

7) Determine adequate resources are available to conduct the clinical trial

8) Ensure the adequate time to conduct and supervise the clinical trial

9) Ensure that the adequate qualified staff to conduct the clinical trial

10) Oversee study start-up training of staff

11) Manage the medical care of subjects

12) Ensure that a qualified physician is responsible for all trial-related medical decisions

13) Review medical and medication history, read ECG tracings, review of subject eligibility of study criteria, safety and other laboratory results and assign clinical significance to results

14) Assess the subject's compliance with the test article and follow-up visits

15) Assess the subject’s response to therapy

16) Evaluate adverse events and ensure that medical care is provided to a subject for any adverse event

17) Inform a subject when medical care is needed to treat any current illnesses

18) Inform the subject’s primary physician about the participation in the trial

19) Review safety reports relevant to study drug

20) Protect the rights and welfare of subjects

21) Report all serious adverse events immediately to the sponsor and IRB

22) Obtain a signed and dated informed consent from the subject and subject’s legal representative prior to initiating any study-related procedures

23) Inform the subject and legal representative about all aspects of the clinical trial

24) Provide new information about the study

25) Ensure the validity of the data reported to the sponsor

26) Ensure the accuracy, completeness, legibility and timeliness of the case report forms

27) Ensure the case report forms accurately reflect source documents

28) Endorse changes and corrections to a case report form

29) Ensure the documentation of study-related procedures, processes and events

30) Maintain trial documents as required by the regulations and sponsor for the appropriate time frame and under secure conditions

31) Provide study reports as requested by the sponsor, IRB and regulatory authorities

32) Ensure the proper use and storage of investigational agents

33) Assume responsibility for the investigational product at the trial site

34) Ensure the proper use and storage of the investigational product at the trial site

35) Assign responsibility to the appropriate research pharmacy personnel

36) Direct the site clinical operations

37) Meet regularly with the Research Team to discuss subject participation and protocol progress

38) Ensure that all research staff are informed about the protocol and investigational agents

39) Participate in monitoring visits and audits, as appropriate

40) Delegate authority at the site appropriately

41) Maintain a list of qualified persons and their corresponding trial-related delegated duties

42) Evaluate study participation and selection

43) Participate in the development of the study participation strategies, as requested

44) Review identified protocols for applicability to site’s capabilities and decide on accepting and declining the clinical trial

45) Assist in study questionnaires, as requested

46) Meet with CRAs and monitors during pre-study visits


Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the clinical research industry is strongly preferred

4) Preference will be given to candidates with recent experience in the investigation

If you are qualified and aspire to work for an excellent, established company whose employees believe in teamwork and make great contributions to the industry, then this could be a golden opportunity for you. Please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 14 Oct 2021, 1:07 PM