Clinical Research Assistant Require at Tata Medical Center

The Tata Medical Center (TMC) is a multispecialty institution for tertiary cancer care based in New Town, Kolkata. At TMC, clinical and research activities are integrated to provide state-of-the-art care for patients with cancer. This integration is enabled by the Tata Translational Cancer Research Centre (TTCRC), the research arm of TMC.

Post : Clinical Research Assistant Hamsyl®/Hamsyl® Jr Phase IV Clinical Trial

Clinical Trial : A phase-IV, open label, prospective, non-comparative, multi-centric, interventional study to assess the safety of Hamsyl®/Hamsyl® Jr. in newly diagnosed ALL patients in India during the induction phase of chemotherapy. Title of the Study: To assess safety of Hamsyl® in a phase-IV clinical study for the treatment of newly diagnosed patients of acute lymphoblastic leukemia (ALL).
Sponsor : Gennova Biopharmaceuticals Ltd
Phase of the Study : Phase IV

Study Objectives :
Primary objective :
• To assess the safety of Hamsyl®/Hamsyl® Jr. for the treatment of newly diagnosed patients suffering from ALL. Secondary objective:
• To assess the asparaginase activity post each dose of Hamsyl®/Hamsyl® Jr.
• To assess the depletion of asparagine amino acid.
• To assess the response criteria for bone marrow remission at the end of induction phase of chemotherapy.
• To assess the anti-asparaginase antibody level post induction phase of chemotherapy. Study outcomes.

Minimum required qualifications / experience
(a) MSc in Biological Sciences, including Life Sciences, Biotechnology, Microbiology, Health Science
(b) Knowledge of GCP, regulatory requirements, and clinical trial processes.
Desired experience :
(a) Prior experience (1-2 years) in handling clinical samples, patient plasma processing, management of data tracker.
(b) Knowledge of protein biology particularly protein/plasma extraction from blood and bio separation techniques like gel electrophoresis, chromatography etc.
(c) Familiarity with working in hospital environment and coordinating between patient and Clinician is highly desirable.
(d) Proficiency in data entry and computer applications.
(e) Strong organizational, communication, and interpersonal skills

Key Responsibilities:
Data & Documentation :
(a) Collect, process, and manage study sample and data, ensuring accuracy and completeness.
(b) Assist in preparing and managing study-related documents (protocols, reports, regulatory submissions).
(c) Assist PI in tracking and reporting adverse events (AEs) and protocol deviations.

Site & Trial Operations :
(d) Ensure compliance with study protocols, SOPs, GCP, and applicable regulations.
(e) Order, manage, and track study supplies and materials in co-ordination with CRO.
(f) Coordinate with investigators, coordinators, IRB and patient follow ups.
Reporting & Compliance:
(g) Monitor study progress, maintain quality control, and ensure data integrity.
(h) Assist in writing progress reports and summarizing findings.

Essential qualities
(a) Integrity, motivation, enthusiasm
(b) Focus and commitment in carrying out tasks and duties
(c) Critical analytical and problem-solving skills, capable of independent work
(d) Ability to work effectively as part of a multidisciplinary team
(e) Clarity in career and professional development goals

Appointment to the position will be for a period of 1 year. Extension of the tenure would be subject to continuation of the Clinical Trial.

Enquiries
(a) For further details on TMC and TTCRC, visit tmckolkata.com
(b) Submission of applications by e-mail to :
1) Dr. Suvasish Mukherjee, Head HR E-mail: suvashish.mukherjee@tmckolkata.com
2) Mr. Satadru Dey, TTCRC E-mail : satadru.dey@ttcrc.tmckolkata.org
(c) For informal enquiries,
1) Dr. Trina Dutta, TTCRC-TMC E-mail : trina.dutta@ttcrc.tmckolkata.org