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Dec 2010 – Till date

Clinical Research Associate I Clinexa Life Sciences Pvt., Ltd., Hyderabad. Core Responsibilities: Project Management

• To supervise all aspects of designated clinical projects with accountability of meeting agreed timelines, budgets and performance metrics.

• To create and maintain laboratory manuals and other study related documents

• To develop and present clinical laboratory presentations at Investigator meetings

• To design specifications and monitor the production of specimen collection kits

• To serve as a primary contact for clients regarding all aspects of assigned projects

• To serve as a primary contact and co-ordinate with vendors and facilitate constant supply of clinical trial materials to trial sites.

• To arrange for the entire logistic supply chain of clinical trial materials for the laboratory.

• Responsible for handling projects and maintaining the quality of these projects

• Responsible for evaluating and analyzing performance of clinical team members

• Maintaining a good rapport with the team members

Address # 12-2-717/1/4, Sapthagiri Nagar Colony, Nanal Nagar, Date of Birth 11 May 1987 E-mail saiphani.gcrs@gmail.com Phone no. +91 9966465033

Important Highlights:

Strong understanding of clinical trial methodology

Firm understanding of ICH GCP, ICMR, Schedule Y, USFDA and other applicable guidelines.

Strong working relationship and good rapport with Clinical Investigators throughout the country.

Experienced in planning & conducting Investigator Meetings and numerous other corporate events.

Expert in managing feasibility studies for projects in various therapeutic areas. Spearheaded process optimization for quick and effective turnaround.

Professional Employment

Clinical Research Professional with 1+ year of experience seeking further growth in the clinical research industry

Detail and results oriented team player with strong problem solving and effective communication skills dedicated to completion of tasks on plan within predefined quality metrics

Phani Kumar G Curriculum Vitae

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• Effectively communicate study expectations to the sites in terms

of quality, sample collection and packaging, and ordering of supplies.

• Manage timely Lab Data flow from Sites to Data Management Centers and facilitate timely query resolution.

• Ensure accountability and reconciliation of laboratory clinical trial material.

• Identify, discuss, resolve and appropriately escalate issues. Take required measures to prevent recurrence of the issues.

Quality and Training • Adhere to ICH/GCP, global and local SOPs and applicable local

laws and regulations. • Cooperate with Line Manager and Quality Representative (QR) to

ensure audit/inspection readiness at sponsor and site level, at all times.

• Ensure compliance to training schedule. • Mentoring junior staff for overall career development.

Communication/Administration • Comply to guidelines for Ethical interactions with Health Care

Professionals and Good Promotional Practices. • Maintain timely interaction with internal and external customers. • Ensure timely completion of all administrative tasks.

July 2010 – Dec 2010

Clinical Research Coordinator Global Clinical Research Services, Global Hospital, Hyderabad. Core Responsibilities:

• Attending the Investigator’s Meetings and Site Initiation Visits. • Coordinating with PI during screening and enrollment of the

subjects and conducting the visits according to the Protocol, ICH-GCP, EC and other regulatory guidelines.

• Reporting the SAE to the Sponsor and Ethics Committee within the timelines as per ICH-GCP and notifying the quarterly update to the Ethics Committee.

• Filling up of the study specific and Subject specific logs. • Maintaining source documents.

Accomplishments:

Conducted extensive study feasibilities to identify several new investigators and clinical trial sites and developed a strong working relationship with them while maintaining excellent contacts with the existing pool of investigators. Supervised numerous clinical trial sites and also managed a team of lab staff including Medical Technologists and Project Coordinators.

Personal Profile: - Energetic with strong interpersonal skills.

- Effective communication skills

- Strong problem-solving skills

- Excellent self-management and organizational skills

- High personal integrity, and able to relate to and create trust in all.

- Good researcher with a solid approach to achieving tasks and objectives.

- Emotionally mature and confident with strong planning, organizing and supervising abilities.

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• Review of on-site records, case report forms, and source documents for completeness, accuracy, consistency, and compliance.

• Having experience in Inform 4.5, Inform 4.6 and Oracle Clinical RDC and eCRF.

• Electronic Case Report Form entry as per eCRF guidelines and resolve the queries if any.

• Assist clinical sites with IRB/IEC submissions and ensure collection of required essential documents for study start-up and throughout conduct of study.

• To ensure all personnel at study sites are appropriately informed and trained, if necessary, before study starts.

• To develop any necessary aids to allow studies to proceed expeditiously (e.g. newsletter, investigator flow charts).

• To maintain awareness of local regulatory requirements, and to conduct studies in accordance with IPC SOPs, guidelines and ICH Good Clinical Practice guidelines.

• To make regular contact with investigators during the course of studies, to make all is proceeding to agreed protocols and time schedules, and that the data is being recorded accurately and returned to IPC to required timescales.

• Work with the Principal Investigator to clarify, respond to, and resolve adverse events as they arise.

• To maintain effective communication with other members of the clinical team and management.

2009-2010 Post Graduate Diploma in Clinical Research Kriger Global Clinical Research Institute, Global Hospitals, Hyderabad. 2006-2009 Bachelor of Pharmacy Osmania University, Hyderabad.

Education

Computer Skills:

Internet, E-mail Operating Systems: MS-Windows Xp, Windows 7 Packages: MS-Office tools like Word, Excel, Power point, Access, Adobe packages, etc Database tools: Oracle 10g, SAS 9.1, theoretical knowledge on Oracle Clinical v4.5.1, Oracle Clinical v4.5.3.

Languages:

Four: English, Hindi, Telugu.

Interests:

Reading (management, marketing, motivational and lifestyle), choreography, swimming, drawing, painting, handmade art, and traveling.

International Exposure:

Valid Passport without visa.

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• Participated in Indo-American Pharmaceutical Regulatory Symposium-2009 held at Nalanda

College of Pharmacy, Nalgonda. • Participated in ETPS-2009 (Emerging Trends in Pharmaceutical Sciences) held at SangaReddy,

Medak. • Participated in Biopharmacon-2k7, a national seminar on biotechnology, pharmacy & chemical

engineering, held at Visakhapatnam.

Project Report • I have done a project on “Evaluation of Antibacterial & Anthelminthic activities of flower

extracts of some medicinal plants” as part of my graduation.

Leadership and Co-curricular Achievements • Performed Class Representative Role for my class in my graduation. • Performed the role of Student Representative for College Library. • Performed the role of Student Representative for College Cultural Committee.

Available on request

Workshops and Conferences

Reference