Clinical Research Associate

Sujata Mikkilineni, M.D.

*** ********* ****, **** *********, NJ 08816 • 718-***-****• *****************@*****.*** OBJECTIVE

Adaptive medical graduate skilled in collaboration with physicians and medical staff seeking a position as Clinical Research Associate/Coordinator. Proven experience with data entry and medical terminology. Experience with multiple fields of medicine. Multi-tasker, detail-oriented and team player with excellent interpersonal skills. Effectively communicates with medical personnel, colleagues, and patients.

SKILLS

• Efficient with Microsoft Office Suite (Excel, PowerPoint, Outlook, Word),

• ARIA, ONCORE,EDC, EPIC, ORACLE, iMEDIDATA RAVE, iMEDNET MEDRIO,ENCAPSIA, Inform

• Ability to travel without limitation • Successful problem solver

• Strong Electronic Medical Record skills • Advanced knowledge of medical terminology

• Extreme attention to detail • Great work ethic

• Excellent time management, multitasking and organizational skills • Team player

• Adaptable and flexible • Clear verbal and written communication skills CERTIFICATIONS

• Good Clinical Practice (GCP) certified

• Sollers College ( Clinical Trial Management Course & Internship) May 2021 to November 2021

• CCRA (Clinical Research Associate)

• Registered Medical Practitioner to practice Medicine in India issued by Andhra Pradesh Medical Council/IMC License # 34538.

• Certification in Basic and Advanced Cardiac Life Support (BCLS, ACLS)

• Phlebotomy, EKG Certification and Pharmacy Certifications.

• Pharmacovigilance

EXPERIENCE

Clinical Trial Coordinator Nov2024-April 2025

RCCA(Regional Cancer Care Associates)

• In collaboration with the Director of Clinical Trials, support the study operational strategies

• Assist with budget monitoring including invoicing and confirmation of site payments

• Develop meeting agendas, minutes and track follow-up actions

• Ensure eTMF oversight including routine quality checks to maintain a complete and inspection-ready state

• Maintain a vendor and site contact list

• Work with the clinical operations team to maintain clinical trial scorecards for routine review

• Assist clinical sites with questions and resolve queries

• With oversight from the Director Clinical Trials, provide support to the multifunctional team on special initiatives as needed

• Create and improve upon business processes to ensure RCCA’s successful growth Research Study Coordinator Sep2021-Jan2024

CINJ (Cancer Institute of New Jersey)

• Knowledge of the cancer disease process, including all applicable medical terminology, anatomy and physiology and medical procedures.

• Collected and analyzed patient data by maintaining accurate and confidential patient medical records throughtout the study.

• Utilize EPIC reports to identify reportable cancer cases.

• Familiarized with the ICD-10 coding systems and AJCC (American Joint Committee on Cancer) Staging Systems and multiple primary & histology rules.

• Finding Cases that involve reading pathology reports and medical records for every patient within the hospital who has been diagnosed with cancer.

• Enters patient demographic and medical information into the cancer (Oncology) database (EDC)

• Strictly adheres to all applicable regulations and guidelines that govern cancer data collection, including the compliance with HIPAA and state-specific regulations, while maintaining full patient confidentiality.

• Resolving queries and interacting with sponsors.

• Actively attends and participates in departmental, organizational and/or educational meetings, as requested.

• Maintains annual competencies set forth by department and organization

• Performs other duties/projects as assigned to support the oncology department. Study Coordinator Jan 2019 - April 2019

Cardiac Metabolic Institute, NJ

• Plan and direct clinical research projects and trials in accordance with principal investigator’s directions, GCP guidelines,and CFR 21 regulation

• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory policies

• Assess eligibility of potential subjects through methods including screening interviews, medical record reviews, or discussions with physicians and nurses

• Provide staff training and professional development opportunities

• Obtain and document informed consent of participants

• Maintain precise records of research activity, including case reports, informed consent forms, regulatory documents, and drug dispensation records

• Collaborate with ethics committee to ensure that research activities adhere to the highest standards

• Design and implement protocols for clinical research trials

• Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.

Phlebotomy and EKG Course Instructor

Middlesex County College, Edison, NJ April 2016 – Dec 2018

• Instruct students in all aspects of the Phlebotomy Technician scope of practice.

• Evaluate, report and record student performance and progress.

• Prepare students in a 72-hour class to go on to a 40-hour externship in a lab or hospital.

• Assists students to develop an understanding of values, attitudes, and ideals appropriate to the health care profession.

• Provides a professional role model for students.

• Utilizing the training syllabus, equipment, and learning materials to give the best learning experience to our students

• Teaching proper venepuncture techniques, anatomy, or physiology. Supervisory Program Coordinator

India Home, Queens, NY Aug 2008 – April 2012

• Supervising and coordinating Community Health Education, including teaching, and conducting diverse range of educational workshops and classes on vital topics to Senior Citizens at various India Home Centers.

• Supervise and review all useful information provided to senior citizens in the form of books, handouts, and websites.

• Supervise basic computer training provided to Senior citizens

• Supervise steps and programs in Preventing Social Isolation to improve senior citizen’s quality of life.

• Supervise program activities by senior citizens such as yoga, exercise, arts and crafts, memory games, birthday and holiday celebrations, trips to museum, shows, cruise, and other sight-seeing locations in and around NYC.

• Supervise congregate meal service with nutritionally and culturally appropriate food and diets. Senior Clinical Research Coordinator/Asst. Manager Neeman Medical International Oct 2005—Aug 2006

• Record all necessary patient observations, related information, and data collection.

• Maintaining source documents E.g. CRF’s, Lab reports, x-ray reports etc.

• Prepare and Interact with the study site personnel for audits, assist the auditors, and organize and prepare documents as required by study monitors. .

• Study Audit Preparation and follow up. Attend meetings held by execution of protocol

• Assure compliance with GCP, ICH, local and other client regulatory requirements.

• Conduct study close out. .

• Attend various meetings for study development and proper execution of protocols.

• Work with potential Investigators to assess feasibility studies to consider for awards and participation. Study Coordinator Behavioral Research of Staten Island Staten Island University Hospital May 2000—Oct 2002

• Site & Investigator identification, evaluation, preparation and assist Principal Investigator at the site.

• Assist in patient enrollment, explain informed consent to the patient and ensure patient safety.

• Performed Laboratory procedures such as Phlebotomy & EKG on patients.

• Conduct clinical studies as specifically related to the protocols and follow standards of good clinical practices.

• Report (AEs & SAEs) according to all applicable GCP / ICH guidelines and client requirements AND follow-up with IRB/IEC communications, and Protocol Deviations.

EDUCATION

Bachelor of Surgery and Medicine, M.B.B.S Lady Hardinge Medical College – New Delhi, India 1984-1991

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