Roles and Responsibilities:1. Ensure inspection readiness through a complete, accurate and readily available Trial Master File. 2. Provides process support for TMF creation, maintenance, closure and archival. 3. Work on cross functional teams including Project Management, Business Development, Client Services, Development, and IT on the implementation and management of client projects. 4. Provide mentoring to the Clinical Document Specialist as needed. 5. Lead Clinical Document Specialist Team. 6. Ensure eTMF staff has adequate resources to carry out their routine activities. 7. Work on eTMF process improvement, effectiveness, and efficiency in consultations with Head of Operations. 8. Design, track and improvise on eTMF team metrics.

Roles and Responsibilities:1. Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), ICH GCP guidelines and study specific TMF Plans.2. Review of list of final documents during the File Review preparation stage, process to catch easily seen subject line discrepancies and duplicates. 3. Effectively communicate and drive document management compliance and quality issues to the clinical study teams and management. 4. Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified. Follow with action owners for Open TMF Issues. 5. Participate in client or Internal audits and document archiving activities as necessary.

Roles and Responsibilities:1. Responsible for day-to-day management of an Ethics Committee and Clinical Operations.2. Conduct / coordinate meetings of the IRB/IEC and support / documentation follow-ups to the members as and when required on related matters.3. Keeping up to date with changes in regulatory guidelines. 4. Coordination of Research Meetings.5. Coordinates with PI, central administration and other stakeholders to ensure that clinical research and related activities are performed in accordance with federal regulations, sponsors policies, and SOPs.6. Perform day to day supervision of research staff for assigned projects.7. Act as primary contact for research team for any questions and concerns.8. Coordinate with management in budget preparation and expense control activities.9. Analyze and resolve research issues in a timely and accurate manner.

Roles and Responsibilities:1. Coordinates with PI, central administration and other stakeholders to ensure that clinical research and related activities are performed in accordance with federal regulations and sponsors policies and procedures.2. Assists PI to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and ICH GCP.3. Collaborates with PI & IEC to respond to any audit findings and implement approved recommendations.4. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to protocol requirements, schedule of visits, execution of research plan. 5. Maintain Site master files and Trials master files.6. Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.7. Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.8. Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).9. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.10. Collects data as required by the protocol. Assures timely completion of Case Report Forms11. Retains all study records in accordance with sponsor requirements and policies and procedures.12. Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.13. Communicate with EC member to conduct successful meeting and also responsible for writing meeting minutes and file the same at appropriate place.

Roles and Responsibilities:1. Identify mistakes in reports, and check with doctors to obtain the correct information.2. Perform data entry and data retrieval services, providing data for inclusion in medical records and for transmission to physicians.3. Produce medical reports, correspondence, records, patient-care information, statistics, medical research, and administrative material.4. Return dictated reports in printed or electronic form for physicians' review, signature, and corrections, and for inclusion in patients' medical records.5. Review and edit transcribed reports or dictated material for spelling, grammar, clarity, consistency, and proper medical terminology.5. Take dictation using either shorthand or a stenotype machine or using headsets and transcribing machines; then convert dictated materials or rough notes to written form.6. Transcribe dictation for a variety of medical reports such as patient histories, physical examinations, emergency room visits, operations, chart reviews, consultation, and/or discharge summaries.8. Translate medical jargon and abbreviations into their expanded forms to ensure the accuracy of patient and health care facility records.9. Answer inquiries concerning the progress of medical cases, within the limits of confidentiality laws.10. Perform a variety of clerical and office tasks, such as handling incoming and outgoing mail, completing and submitting insurance claims, typing, filing, and operating office machines.11. Receive patients, schedule appointments, and maintain patient records.12. Set up and maintain medical files and databases, including records such as x-ray, lab, and procedure reports, medical histories, diagnostic workups, admission and discharge summaries, and clinical resumes.