Clinical Research Specialist

Job Title: Clinical Research Specialist

Experience: 3-4 years of experience in clinical operations department of a CRO/Pharma/Biotech organization

Direct Reports :- No Dotted Line Reports:

ROLE AND RESPONSIBILITIES

Clinical operations:-

The overall efficient day-to-day management of the trial.
Identify investigator sites and conducting feasibilities and qualification visits.
Conduct site initiation, site monitoring and site close-out activities.
Ensure timely recruitment of trial participants and subsequent efficient and effective data management.
Plan Investigational Product and other related trial material requisition, procurement and dispatch.

Job Description – Clinical Research Specialist Version

Plan and conduct Investigator’s Meeting
Lead & guide data query resolutions
Ensure timely reporting of SAEs, SUSARs to regulatory authorities and reporting of SAEs to all sites and investigators.
Management of the trial budget(s) and maintenance of the accounts.

Systems & processes:
Establishment & execution of procedures to ensure adherence to GCP, trial protocols, applicable regulations and administrative requirements.
Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
Handle audits & inspections and CAPA management

Stakeholder management:
Act as the point of contact for all external and internal agencies
Coordination with investigator and sites for executing clinical study agreements & financial agreements.
Coordinate with internal stakeholders (Medical, Regulatory, QA etc.) for timely regulatory submissions
Work closely with TA SPOC medical advisor for study related activities
Vendor management as per Dr.Reddy’s applicable policies & procedures
Document management:
Preparing & reviewing clinical trial documents with clinical trial assistant (CTA) for Ethics committee & DCGI and/or other regulatory submission (as applicable).
Reviewing clinical trial protocols, CRF, Diaries (if applicable), PIS-ICF, IB, CSR, study-specific logs, SAE narratives, ICSRs, SOPs, PSURs and mansucripts

Preferably 3 to 4 years working experience in the clinical operations department of a CRO/Pharma/Biotech organization
Must have experience in handling large clinical trials with multiple sites for different therapeutic areas
Must have experience in handling audits & inspections
Training in clinical trial methodologies, research design and ICH – GCP
Must have working knowledge of Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals
Strong academic record with strength in research with knowledge of research methodologies
Experience with complex business environments preferred
Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.

COMPETENCY REQUIREMENT

Execution excellence
Effective & efficient collaboration skills
Integrity driven decision making skills
Sound scientific knowledge
Strategic thinking & sound analytical skills
Sense of urgency & desire to excel
Intellectual curiosity
Self-awareness and adaptability to work in a matrix environment
Result oriented and performance driven
Excellent interpersonal & communication skills to effectively interact with a broad range of audience.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS
The role is majority office based and involve execution of clinical development projects

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