Clinical Research Physician Resume
Summary : As a Clinical Research Physician, Conducted all clinical trials (studies) according to ICH GCP, local regulations, study protocol, and company processes. Ensured the medical well-being and safety of the participants through the safe performance and execution of the studies. Maintained clinical oversight and quality on the studies registered on and delivers on study targets, thereby contributing to the commercial success of the site which includes recruitment, enrollment, and retention of study participants.
Skills : Knowledge of medical terminology, Clinical research.
Description :
- Executed all appropriate Investigator responsibilities on assigned projects. Supported the implementation and application of ClinBase™ in the EPCU.
- Supported Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient and compliant clinical operation of the EPCU.
- Assisted with the medical and clinical oversight of all aspects of function and work performed within the EPCU.
- Assisted with training and input on performance assessments for clinical operations personnel.
- Worked directly with clinical operations personnel in reviewing laboratory data, performing physical assessments, medical histories, and evaluation of inclusion/exclusion criteria for study participants.
- Participated in the review and coding of adverse events and concomitant medications for accuracy and consistency.
- Provided medical consultation as required or requested by the client/sponsor or the PAREXEL-Baltimore EPCU staff.
Experience
10+ Years
Level
Senior
Education
MBBS
Clinical Research Physician Resume
Summary : As a Clinical Research Physician, I Oversaw facility teammate training programs to ensure the effective execution of research tasks performed by the clinic staff. Worked closely with Compliance, Privacy, and JLD to ensure study activity is executed within the guardrails of compliance, and patient privacy, and within a HIPAA-compliant manner.
Skills : Analytical and problem-solving.
Description :
- Provided support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested.
- Participated in on-call and general physician coverage schedules for the EPCU. Established working relationships with client representatives, promoting confidence and reliability regarding the EPCU’s operations.
- Represented PAREXEL-Baltimore EPCU to clients in a positive and professional manner. Provided support for marketing activities as requested.
- Liaised with sponsors on study conduct and study progression as requested. Liaised with physician staff of MedStar Health and local/regional medical consultants as necessary.
- Participated in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and if noted, follow-up as appropriate with the clinical team, project team sponsor, investigator, and regulatory agencies.
- Participated in the review of individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity, and seriousness.
- Provided reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis summarizing adverse experiences as required by the FDA or the sponsor as needed.
Experience
7-10 Years
Level
Management
Education
MBBS
Clinical Research Physician Resume
Summary : As a Clinical Research Physician, Developed and oversaw effective training tools to integrate clinical studies into clinic daily operations in order to minimize study deviations and maximize patient participation opportunities. Facilitated timely issue escalation and resolution for physicians, study teams, and clinic issues as it relates to clinical research execution.
Skills : Communication and Interpersonal skills.
Description :
- Ensured that all established timelines relating to areas of responsibility and assigned projects are met.
- Ensured that the quality standard of clinical work product is met. Carried out clinical evaluation and assessment of participants to ensure eligible participants are enrolled in studies.
- Reviewed enrollment progress, pre-screening and screening success rates, screen failure rates, safety, and retention of participants.
- Interpreted protocols and IB and participate in initiatives to strategize for patient recruitment.
- Ensured and protected the welfare and safety of participants through ethical conduct; this should receive the highest priority at all times during all aspects of the study.
- Fulfilled and complied with all medical duties as per protocol, SOP/COP and ICH GCP, and local regulations.
- Reported any safety threats, that may impact stakeholders/participants and action complaints or QIs as per site processes.
Experience
7-10 Years
Level
Management
Education
MBBS
Clinical Research Physician Resume
Summary : As a Clinical Research Physician, I Oversaw and managed clinical and protocol-related deviations that occur in DaVita facilities. Worked collaboratively with other DaVita support organizations to mainstream research into the DaVita healthcare operations utilizing existing channels and developing new workflow processes while maintaining current knowledge of DaVita facility clinical programs.
Skills : Leadership and Team Management.
Description :
- Exercised meticulous attention to detail in recording information and source management.
- Oversaw the management of investigational medical products (IMP). Protected the rights, safety, and welfare of participants under their care.
- Ensured that the clinical trial is conducted according to the investigational plan and all applicable regulations.
- Administered test articles to the subjects, or delegated this to nursing staff where appropriate.
- Reviewed and evaluated protocols and provided clinical and scientific support. Interacted with regulatory bodies as relevant to clinical operations.
- Attended study initiation meetings. Presented protocols at IRB/IEC meetings, as required
- Assisted Operations and Client Managers with sponsor visits. Performed pre-study physical examinations and review lab data and all inclusion/exclusion criteria to ensure volunteers are medically and mentally fit upon entering the study.
Experience
7-10 Years
Level
Management
Education
MBBS
Clinical Research Physician Resume
Headline : As a Clinical Research Physician, Served as a clinical protocol specialist for DCR teammates, field teammates, and physicians. Worked with the Medical Director, Nephrology Services in the assessment of protocols for scientific merit and feasibility of implementation into DaVita facilities. Directed and implemented communication strategies to our physician partners, DaVita clinic operations, and facility teammates.
Skills : Statistical methods, Clinical Skills.
Description :
- Performed on-study and post-study physical examinations to ensure that the physical and mental well-being of volunteers is undiminished at the end of the study.
- Informed Principal Investigator, IRB/IEC, and Sponsor as appropriate of relevant events.
- Reviewed and signed CRFs at the conclusion of the study. Acted as Principal Investigator/Co-Investigator as assigned by the Medical Director.
- Performed, and screened assessments including physical examinations, and medical history review; reviewed results of diagnostics studies, and evaluates subjects with regard to suitability for clinical research studies.
- Counseled subjects with regard to abnormal and/or exclusionary diagnostic results, as necessary.
- Accurately completed source documents. Demonstrated legible handwriting.
- Applied expert medical knowledge to monitor subjects selected for participation in ICON’s clinical research studies.
Experience
5-7 Years
Level
Executive
Education
MBBS
Clinical Research Physician Resume
Objective : As a Clinical Research Physician, Prepared clinical development plans and instituted properly approved clinical protocols. Led cross-functional teams comprised of multidisciplinary professionals and clinical scientists. Contributed to and supported Department/Clinical initiatives to improve the quality and content of all clinical programs and the cross-functional/organization processes designed to effectively deliver our R&D portfolio.
Skills : Planning, Developing.
Description :
- Provided medical care and emergency care for study subjects, as necessary. Maintained certifications for BLS and ACLS.
- Achieved and/or maintained Board certifications. Maintained knowledge/skills/proficiency with regard to clinical evaluations, ECG, and diagnostic study interpretive abilities.
- Demonstrated up-to-date, accurate, working knowledge of ICON’s Standard Operating Procedures, Work Instructions, and details of study-specific protocols to ensure regulatory compliance.
- Executed duties responsibly and ethically to ensure the ethical conduct of clinical research studies at ICON.
- Performed duties accurately and within timelines to avoid unnecessary wastage of valuable resources.
- Contributed to a constructive and collaborative culture within ICON’s medical team and interactions with other ICON personnel.
- Displayed positive role model as leader of the healthcare team at ICON.
Experience
2-5 Years
Level
Executive
Education
MBBS
Clinical Research Physician Resume
Objective : As a Clinical Research Physician, Worked with the Therapeutic Area Head and other team members to prepare abstracts, manuscripts, and presentations for external meetings and author clinical sections of regulatory documents (IB, IND sections). Designed and conducted early clinical Phase 1 and Proof-Of-Concept development trials, assess clinical safety and efficacy data, and write clinical study reports, clinical sections of INDs, and Investigator Brochures.
Skills : Designing, Clinical Skills.
Description :
- Coordinated with Quality Team to ensure teammates are trained on Standard Operating Procedures, research regulations, and applicable healthcare regulations.
- Participated in Late Phase operations reviews on a quarterly basis.
- Participated in strategic planning to develop and maintain programs related to research integration and physician experience.
- Worked closely with biomarker, discovery, and translational research scientists.
- Provided user training and ensured the availability of documentation.
- Ensured the availability of sops and guidelines work instructions for system use.
- Ensured controlled access to the system. Evaluated and decided on recommended change actions.
Experience
2-5 Years
Level
Executive
Education
MBBS
Clinical Research Physician Resume
Objective : As a Clinical Research Physician, Actively contributed to developing and reviewing Standard Operating Procedures and Working Instructions in the role of process owner and subject matter expert (Electronic document system (EDMS)). Led as a business owner of certain Standard Operating Procedures and Working Instructions the regular update of these documents. Actively contributed to the validation and implementation of new systems, instruments methods, and assessments.
Skills : Researching, Problem Solving.
Description :
- Ensured that these systems are documented in the Validation Master Plan.
- Supported the Medical Leader/Clinical Leader and provides active scientific contributions to a cross-functional clinical team developing a compound currently being studied for new oncology applications.
- Coordinated and worked collaboratively with research scientists and clinical site personnel (physicians, NPs, and nurses) in patient subject recruitment, consenting, record maintenance, and research sample acquisition and transportation.
- Ensured study data are collected accurately, and maintained in an orderly and easily retrievable manner. Obtained minimally invasive research specimens (e.g., nasal wash, phlebotomy).
- Comforted with both paper charts and electronic medical records (EPIC system). Coordinated with both information technology staff and research staff in the maintenance of database systems.
- Assisted the Director and Assistant Director of the RGHRI in outreach activities to clinical sites, IRB approvals, grant processes, and data reporting to sponsors, funding institutions, and manuscripts.
- Traveled between local research sites (urban and suburban Rochester). Lead the development of the clinical strategic plan for the program/therapy area.
Experience
2-5 Years
Level
Executive
Education
MBBS
Clinical Research Physician Resume
Objective : As a Clinical Research Physician, Participated in the organization, coordination, and execution, as required, of internal meetings and external medical/scientific meetings, Investigator Meetings, and clinical/scientific advisory board meetings. Led and actively participated in the training and coaching of on-call staff and new and less experienced colleagues
Skills : Leadership, Collaborative Skills.
Description :
- Managed, forecasted, and allocated resources for the clinical program with support from the Therapeutic Area Head (TAH).
- Performed complete and accurate health histories and physicals whenever necessary.
- Exercised autonomy in decision-making by using sophisticated clinical knowledge to demonstrate a high level of accountability to supervising physicians, research investigators, other staff, and research participants.
- Collaborated with multiple disciplines in the development and implementation of protocol procedures to provide optimal patient care.
- Provided follow-up to research investigators/acted as a liaison between the research center staff and the study investigators to address patient problems and responses to treatment.
- Collaborated with supervising physicians, provides education to study participants and healthcare personnel in regards to medical treatment & follow-up, study procedures, and risks, & the role of the PA by discussion, didactic sessions, and development of materials and programs, as appropriate.
- Assisted in orienting new staff and evaluating the clinical competence of staff. Collaborated with the department administrator and associate program director on education, outreach, quality improvement, and other duties as assigned.
Experience
2-5 Years
Level
Executive
Education
MBBS
Clinical Research Physician Resume
Objective : As a Clinical Research Physician, Acted as part of a multidisciplinary team to provide continuity of care to patients throughout various stages of treatment on protocol and follow-up. Participated in an individualized training/orientation program geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC.
Skills : Researching, Operating.
Description :
- Principle Investigated/Sub Investigated for clinical trials conducted at the Parexel Baltimore Early Phase Unit. Responsible for presentation of medical.
- Provided clinical mentorship and leadership for clinical development and clinical trial conducted within our organization.
- Operated in a wide range of aspects in clinical and pharmaceutical medicine and with patients, health authorities, colleagues, and biopharmaceutical companies.
- Assessed and followed the safety of clinical trial participants and collaborate with the team with all aspects of clinical and scientific input and safety evaluation.
- Provided clinical expertise in the conduct of clinical trials. Built positive relationships and networks with internal and external medical professionals and local opinion leaders.
- Worked closely with colleagues in other functions, Regulatory Affairs, Clinical Operations, and Patient Engagement.
- Led and provided oversight to a team of researchers and clinical staff involved in the conduct of clinical trials.
Experience
2-5 Years
Level
Executive
Education
MBBS
