Closing DateJun 25 2021
Clinical Trial Nurse
Organization: The INCLEN Trust International
Location: SOMAARTH DDESS, Bareilly, Uttar Pradesh
About Us: INCLEN is an international health research organisation dedicated to improving the health of populations by promoting equitable health care based on the best evidence of effectiveness and the efficient use of resources. INCLEN undertakes collaborative, inter-disciplinary research on high proirity health problems.
Since 2009, INCLEN has setup and been managing a demographic development & environmental surveillance site (DDESS) encompassing 51 villages in District Palwal, Haryana (SOMAARTH- Palwal) and 44 villages in District Palwal, Haryana (SOMAARTH- Palwal).
INCLEN is seeking applications for the position of ‘Clinical Trial Nurse’ for drug management, has an in-depth knowledge of ICH – GCP Guidelines and study protocol and is capable of providing comprehensive clinical services for study participants. The appointments will be made as annual rolling contracts.
The incumbent is expected to perform the following tasks:
1. Reviews protocols for The INCLEN Trust International under various Clinical Trials, as required
2. Actively recruits and screens eligible patients for research protocols. Assists and conducts Informed Consent process. Completes Informed Consent quality assurance assignments as needed.
3. Coordinates and implements enrollment and follow-up procedures to collect data from patient charts, medical records, interviews, questionnaires, and other sources. Willing to do home visits if needed.
4. Completes and submits Case Report Forms (CRFs) and pertinent study-related forms accurately and within specified time limits. Resolves any logic checks, errors, queries and delinquencies that come up with strict time-frames. Completes quality assurance assignments.
5. Liaises with principal investigators and/or trial coordinators/research assistants to establish Nurses role, to implement dispensing and administering investigational products.
6. Assures that study-related laboratory tests and diagnostic procedures are completed, reviewed, and confirmed when necessary.
7. Understands regulatory process and IRB requirements, ensuring compliance with regulatory agencies. Completes and maintains regulatory files as assigned. Helps with regulatory submissions to IRB and sponsors.
8. Maintains monthly billing for study visits and documents appropriate fees on research referral forms.
9. Maintains contact with study patients to facilitate study retention and their care, including communication regarding study requirements, coordinates drug dispensing with Research Pharmacist and other procedures, treatment, etc.
10. Communicates with providers, protocol teams, sponsors, IRB, as well as others from the Clinical trial staff regarding the clinical management of signs, symptoms, toxicities, abnormal labs, deviations, adverse events, etc.
11. Provides preceptorship and research trainings to the new and current research coordinators.
12. Updates study schemas/source documentation for studies and assists with overall QA activities for the program.
13. Attends pertinent educational or study activities to include some out of town meeting and reviews on current literature relevant to clinical area. Possible local travel in the community
Essential Qualification and experience:
• Bachelor’s or master’s in Nursing
• Bsc Nursing or GNM course with MPH shall be preferred.
• At least 1 years of relevant clinical trial experience
• Trained in GCP and applicable regulatory guidelines.
• Strong written and verbal communication skills including good command of English required.
• Excellent organizational and problem solving skills.
• Effective time management skills and ability to manage competing priorities
• Basic knowledge of data management and statistical analysis
• Sound knowledge of resource management.
• Experience of handling electronic data capture and its related processes
Remuneration: The incumbent will be compensated in terms of salary and designation comparable to industry standards.
Application procedure: Please email your CV mandatorily in the format attached herewith by 25th June 2021 to email@example.com with subject “CV for Clinical Trial Nurse- Bareilly” Application should be accompanied with Cover letter. Candidates who do not fulfill the essential requirements need not apply.
Please note that CVs in any other format shall not be considered.
For further details about INCLEN, please visit: www.inclentrust.org or call at +91-11-47730000.
THE INCLEN TRUST INTERNATIONAL
FORMAT FOR CURRICULUM VITAE
Post applied for:
4) Marital Status
5) Contact No.
6) Email ID
7) Total Experience
8) Skype ID
9) Qualification: (Latest first)
Name of University/College Degree Year of completion
10) Employment history (starting from the most recent one)
Key Job responsibilities (list not more than 5)
11) Publications (Numbers only)
• Articles in book/Updates:
• Research Papers, Reports:
• General articles:
• Others (Please specify):
12) List of 5 key publications with a brief description (In case of no publications describe key projects/poster presentations/conference presentations/thesis that you have been part of)
13) Relevant training course apart from professional qualification
14) Mother tongue ……………………………………………….
15) Language proficiency
Language Read Write Conversation
16) Technical skills
Software Beginner Intermediate Advanced
Arc GIS/Q GIS
Use of Literature search engines
17) Current CTC (Annual)
18) Expected CTC (if negotiable)
19) Notice Period (if negotiable)
20) Reason for change (Brief description)
21) Current Location
22) Hail From (Location)
23) Ready to relocate to
a. Bareilly (Yes/No)
24) Any other relevant details
Job Email id: firstname.lastname@example.org