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