Clinical Research Physician Job Description

Clinical Research Physician Job Description

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Clinical research physician provides knowledge of and compliance with local laws and regulations and global policies and procedures with respect to data dissemination and interactions with external health care professionals.

Clinical Research Physician Duties & Responsibilities

To write an effective clinical research physician job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical research physician job description templates that you can modify and use.

Sample responsibilities for this position include:

When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs
As local study manager, you are the leader of the local trial team being responsible for the local performance, quality and oversight in multinational clinical trials
Work with Therapeutic Area Head and other team members to prepare abstract, manuscripts and presentation for external meetings author clinical sections of regulatory documents (IB, IND sections)
Design and conduct 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, Investigator Brochures
This individual will also work closely with biomarker, discovery and translational research scientists
Ensures optimal study conduct
Participates in the organization, coordination and execution, as required, of internal meetings and external medical/scientific meetings, , Investigator Meetings and clinical/scientific advisory board meetings
Actively contributes to developing and reviewing Standard Operating Procedures and Working Instructions in the role of process owner and subject matter expert (Electronic document system (EDMS)) Leads as business owner of certain Standard Operating Procedures and Working Instructions the regular update of these documents
Actively contributes to the validation and implementation of new systems, instruments methods and assessments
Leads and actively participates in the training and coaching of on-call staff and new and less experienced colleagues

Clinical Research Physician Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Research Physician

List any licenses or certifications required by the position: BLS, ACLS, NCCPA, PA, BS, BS/MS, PALS, DEA

Education for Clinical Research Physician

Typically a job would require a certain level of education.

Employers hiring for the clinical research physician job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Medical, Business, Medicine, Nursing, Graduate, Health, Hematology, Oncology, School of Medicine, Health Information Management

Skills for Clinical Research Physician

Desired skills for clinical research physician include:

Compliance with local laws and regulations
Global policies and procedures
Compliance guidelines with respect to data dissemination and interactions with external health care professionals
Drug development process
Biology
Drug development process relevant to country/region
Clinical development process and strong relationships with team members
Colleagues and internal and external stakeholders to achieve results
Key areas of early drug development
Local label

Desired experience for clinical research physician includes:

The Director supports medical affairs activities involving product evaluation, labeling and surveillance
The Director Clinical Research, Oncology reports directly to a Medical Leader/Clinical Leader for the product to which he/she is assigned
This position requires a minimum of an advanced degree in medicine
A trained Oncologist (Board certified or Board Eligible or equivalent) is strongly preferred
Applicable post-doctoral fellowship training is required
A minimum of 3 or more years of experience in a clinical research position, in oncology, within the pharmaceutical industry is preferred

Clinical Research Physician Examples

1

Clinical Research Physician Job Description

Job Description Example
Our company is searching for experienced candidates for the position of clinical research physician. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research physician
  • Team leader in the role of PI
  • Responsible for the safety and well-being of the volunteer subjects
  • Act as part of a multidisciplinary team to provide continuity of care to patients throughout various stages of treatment on protocol and follow-up
  • Participate in an individualized training/orientation program geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC
  • Preparing clinical development plans and institute properly approved clinical protocols
  • Leading cross-functional teams comprised of multidisciplinary professionals and clinical scientists
  • Contributing and support Department/Clinical initiatives to improve the quality and content of all clinical programs the cross functional/organization processes designed to effectively deliver our R&D portfolio
  • Serves as a clinical protocol specialist for DCR teammates, field teammates and physicians
  • Works with the Medical Director, Nephrology Services in the assessment of protocols for scientific merit and feasibility of implementation into DaVita facilities
  • Directs and implements communication strategies to our physician partners, DaVita clinic operations and facility teammates
Qualifications for clinical research physician
  • Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important
  • A strong commitment to oncology/hematology clinical research and the ability to work well within a team setting are essential
  • Good oral, written communication and presentation skills (including report development) are essential
  • Travel required may be up to 20 % annually (international, domestic).Clinical Research MD
  • A minimum of 3 or more years of experience in a relevant oncology clinical research position is required
  • Strong oral, written communication and presentation skills (including report development) is required
2

Clinical Research Physician Job Description

Job Description Example
Our company is searching for experienced candidates for the position of clinical research physician. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical research physician
  • Oversees and manages clinical and protocol related deviations that occur in DaVita facilities
  • Works 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
  • Develops and oversees effective training tools to integrate clinical studies into clinic daily operations in order to minimize study deviations and maximize patient participation opportunities
  • Facilitates timely issue escalation and resolution for physicians, study teams and clinic issues as it relates to clinical research execution
  • Oversees facility teammate training programs to ensure the effective execution of research tasks performed by the clinic staff
  • Works closely with Compliance, Privacy and JLD to ensure study activity is executed within the guardrails of compliance, patient privacy and within a HIPAA compliant manner
  • Coordinates with Quality Team to ensure teammates are trained on Standard Operating Procedures, research regulations and applicable healthcare regulations
  • Participates in Late Phase operations reviews on a quarterly basis
  • Participates in strategic planning to develop and maintain programs related to research integration and physician experience
  • You will also work closely with biomarker, discovery and translational research scientists
Qualifications for clinical research physician
  • Discovery Scientists
  • Legal counsel
  • Translational research experience
  • Demonstrated experience supporting regulatory research preferred
  • Review of study documentation (protocol, CRF
  • MD, board certified or board eligible in either Hematology or Oncology, or relevant Medical Specialty preferred
3

Clinical Research Physician Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of clinical research physician. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical research physician
  • Provides user training and ensures availability of documentations
  • Ensures the availability of SOP’s and guidelines (work instruction) for system use
  • Ensures controlled access to the system
  • Evaluates and decides on recommended change actions
  • Ensures that these systems are documented in the Validation Master Plan
  • The Director Clinical Research, Oncology is a member of a matrix team dedicated to the implementation of clinical research studies that are part of a global compound development program
  • The Director supports 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
  • Other functional groups represented on the team include project management, regulatory affairs, global clinical operations, data management, medical writing, biostatistics, medical affairs, clinical pharmacology, and health economics
  • The Director will act as a liaison between the company and the clinical investigators
  • He/She will be participating in the data cleaning, ongoing medical review, data interpretation and reporting of the results of the research, including submission to health authorities
Qualifications for clinical research physician
  • Scientific medical research experience in Hematology/Oncology with demonstrated record of scientific medical publications
  • A high-performing physician-scientist familiar with clinical and translational research involving biomarkers and correlative laboratory clinical trial endpoints
  • This individual will be required to collaborate closely with relevant functions within Janssen Pharmaceuticals including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, personnel from Global Clinical Operations, Global Strategic Marketing, and other support functions
  • In this capacity the successful candidate will works closely with research group leaders, drug discovery teams, and project clinical teams
  • The ability to communicate effectively with basic laboratory scientists and clinical teams is essential
  • The Director is also expected to establish strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners
4

Clinical Research Physician Job Description

Job Description Example
Our company is searching for experienced candidates for the position of clinical research physician. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research physician
  • Coordinate and work collaboratively with research scientists and clinical site personnel (physicians, N.P.’s, and nurses) in patient subject recruitment, consenting, record maintenance and research sample acquisition and transportation
  • Ensures study data are collected accurately, and maintained in an orderly and easily retrievable manner
  • Ability to obtain minimally invasive research specimens (e.g, nasal wash, phlebotomy)
  • Comfort with both “paper charts” and electronic medical record (EPIC system)
  • Coordination with both information technology staff and research staff in maintenance of database systems
  • Assist the Director and Assistant Director of the RGHRI in outreach activities to clinical sites, IRB approvals, grant processes, and data reporting to sponsors, to funding institutions, and in manuscripts
  • Maintenance of appropriate job- and profession-specific certifications and credentialing
  • Travel between local research sites (urban and suburban Rochester)
  • Lead the development of the clinical strategic plan for program/therapy area
  • Manages, forecasts, and allocates resources for the clinical program with support from Therapeutic Area Head (TAH)
Qualifications for clinical research physician
  • At least 4 years of experience in Oncology clinical research in the pharmaceutical industry OR experience in clinical research or medical affairs is preferable or a combination of experience in academic medicine with clinical research and or clinical development experience in collaboration with the pharmaceutical industry
  • An MD/Ph.D
  • Formal training in Oncology or Hematology with Board certification or eligibility is required
  • A minimum of 5 or more years’ experience in clinical research within the pharmaceutical industry or academia is preferred
  • Significant knowledge of translational and clinical cancer research and its application to cancer drug development is of paramount importance is required
  • Knowledge of clinical pharmacology and its relationship to decision making in early drug development is of value
5

Clinical Research Physician Job Description

Job Description Example
Our company is looking to fill the role of clinical research physician. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical research physician
  • Under the supervision and direction of the responsible physician, provides research procedures to study participants in various hospital outpatient clinics and inpatient settings, as assigned and across a continuum of age and acuity
  • Performs complete and accurate health histories and physicals whenever necessary
  • Exercises autonomy in decision-making by using sophisticated clinical knowledge to demonstrate a high level of accountability to supervising physician, research investigators, other staff, and research participant
  • Collaborates with multiple disciplines in the development and implementation of protocol procedures to provide optimal patient care
  • Provides follow-up to research investigators/acts as liaison between the research center staff and the study investigators to address patient problems and responses to treatment
  • In collaboration 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
  • Assists in orienting new staff and evaluating clinical competence of staff
  • Collaborates with the department administrator and associate program director on education, outreach, quality improvement, and other duties as assigned
  • Specific activities include developing or contributing to the regional clinical/medical plan
  • Accountable for the execution of the Clinical programs in China to ensure successful achievements to support products approval in China
Qualifications for clinical research physician
  • Ability to strategize and lead a goal oriented clinical development team will be very valuable.Clinical Research MD
  • Must have experience with study start up and database locks
  • Knowledge of and strict adherence to GCP/ICH guidelines and internal SOPs in Clinical Research and Development
  • Is the key person medically leading the CPU study Team and responsible for the execution of the clinical part of the protocol as pre-agreed with the sponsor
  • Should intensively collaborate with the Clinical Research Coordinator, Laboratory Manager and other members of the study team and leads the team as the overall responsible of the team
  • Is the subject-matter expert, responsible for compliance with the internal quality system

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