Site Solution Executive

Site Solution Executive

Principal Investigator (PI)

This is an excellent opportunity for professionals passionate about clinical research, site operations, and patient safety.

Key Responsibilities:

• Coordinate and facilitate all

  clinical trial activities at the site

  , ensuring compliance with study protocols, GCP, and local regulations.
• Support the

  Principal Investigator (PI)

  and site team in meeting all sponsor and regulatory requirements.
• Review and streamline

  site processes

  , identify operational gaps, and support implementation of process improvements.
• Perform

  timely data entry

  into Case Report Forms (CRFs/eCRFs) in consultation with the PI.
• Maintain all

  clinical trial documentation

  , including

  Trial Master File (TMF)

  and study records.
• Prepare for and assist during

  site initiation

  ,

  monitoring

  ,

  close-out visits

  ,

  QA inspections

  , and

  sponsor/CRO audits

  .
• Report

  site performance metrics

  at defined intervals.
• Coordinate

  ethics committee submissions

  , including protocol, safety reports, and periodic updates, and maintain all related correspondence.
• Support

  patient scheduling, screening, and enrolment

  as per protocol requirements.
• Ensure timely availability and correct storage of

  Investigational Products (IP)

  ,

  lab kits

  , and other study materials; maintain IP accountability and temperature logs.
• Organize

  laboratory sample pickups

  , ensuring accurate tracking and documentation.
• Assist in

  data query resolution

  and ensure accuracy of source documents.
• Maintain

  regular communication

  with site monitors, CRO representatives, and study sponsors.
• Facilitate effective communication between investigators, site staff, and sponsors.
• Support

  patient-awareness programs, investigator meetings

  , and

  training initiatives

  at the site.
• Maintain a

  database of potential patients

  for ongoing and upcoming studies.
• Identify potential

  site challenges

  and propose

  mitigation strategies

  in coordination with the Line Manager (LM), Trial Site Manager (TSM), and PI.
• Ensure

  timely completion of all required SOP and GCP training modules

  .
• Notify Sponsor/CRO representatives of

  external audits or inspections

  , assist in responding to findings, and implement approved corrective actions.
• Escalate any systemic non-compliance or misconduct to management for appropriate follow-up.
• Direct all

  feasibility-related requests

  to the appropriate

  feasibility team at the Clinical Site (CS)

  .

Qualifications & Experience:

• Bachelors or Masters degree

  in Clinical, Biological, or Mathematical Sciences, or a related field.
• Alternatively, a

  Medical, Dental, or Nursing qualification

  is acceptable.
• Candidates without the above qualifications must have

  a minimum of 4 years experience

  working in clinical research sites.
• Strong

  oral and written communication

  skills in

  English

  and at least one

  local Indian language

  .
• Excellent

  interpersonal, coordination, and organizational skills

  .
• High level of

  attention to detail

  , documentation accuracy, and commitment to timelines.
• Sound understanding of

  ethical standards

  ,

  patient rights

  , and

  clinical trial integrity

  .
• Proficiency in

  MS Office

  and other standard computer tools used for documentation and communication.
• Demonstrated ability to work in a

  collaborative, fast-paced, and regulated environment

  .

Contract Details:

• Duration:

  1 Year (Contractual)

• Location:

  Mysore (On-site Role)

• Reporting To:

  Site Manager / Principal Investigator