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PV Research Physician

Employer
Planet Pharma Staffing Limited
Location
London (Greater) (GB)
Salary
Attractive
Start date
15 Jan 2021
Closing date
14 Feb 2021

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Discipline
Medical Affairs, Clinical Research Physician
Hours
Full Time
Contract Type
Permanent
Experience Level
Entry level

Job Details

JOB SUMMARY

Amazing opportunity to join a specialist CRO who operate with clinical excellence from design to delivery of early phase clinical trials. Their integrated platform is designed to streamline every aspect of Early Phase trial with quality, integrity and accuracy!.   

This role will be be working with a high level PV Scientist to put in place their PV system around reporting adverse events 

The requirements below show the breadth of work covered by the Research Physicians and Senior Research Physicians within this Global Contract research organization. The focus of an RP’s work is expected change with seniority. In general, the specification shown below is presented in a probable chronological order i.e., the focus of work progresses down the specification with seniority.  

REQUIREMENTS

Volunteer screening in preparation for clinical trials

  • To obtain informed consent from subjects prior to inclusion into a study.
  • To perform medical screening on healthy volunteers and patients including medical history taking, physical examination and review of laboratory reports according to the study protocols.
  • To collate necessary medical documents and information to make informed decisions about inclusion onto a clinical trial.
  • To review all Case Report Forms with regard to inclusion/exclusion of subjects prior to commencement of the study.
  • To liaise closely with volunteers and patients enrolling for clinical trials, their relatives if necessary.
  • To liaise with volunteers’ and patients’ own doctors, including specialist staff, when required.
  • To liaise closely with the recruitment staff regarding screening status, drop outs, withdrawals, replacements, follow-up appointments etc.
  • To maintain detailed reports of all screened volunteers and communicate screening progress to relevant departments.

 Clinical trials procedures

  • To be familiar with all current study protocols.
  • To discuss protocols in-house and with sponsors and experts.
  • To supervise all safety aspects during the studies.
  • To maintain knowledge, understanding and practice of general medical practice and to maintain Advanced Life Support skills.
  • Evaluate and treat all Adverse Events that arise during studies and prepare safety reports.
  • To ensure a safe discharge from the unit and to conduct follow-up examinations after completion of the study.
  • To participate in and supervise (as member of Project Teams) study procedures as drug administration, safety measures and other study methodology.
  • To keep up to date with all Research Unit activities through regular participation in study-related meetings in the unit.
  • To keep up to date with relevant ICH GCP issues and developments and to adhere to them at all times
  • To work to RPL Standard Operating Procedures (SOPs), laws, guidelines and rules at all times.
  • To co-operate with the Training Department and the Quality Assurance and Monitoring Departments in the maintenance of records for the preparation of audits, inspections and other visits.
  • Ensure accurate and complete recording of data
  • To collaborate with the Quality Control (QC) and Data Management (DM) departments and external monitors to resolve data queries.

Reporting

  • To produce and update case reports for volunteers who experience Serious Adverse Events or other notable Adverse Events.
  • To review and analyse safety, pharmacokinetic and pharmacodynamic data and present the findings in interim reports.
  • To participate in the discussions regarding the impact data in interim/safety reports has on clinical trial progression.
  • To assist with the review and analysis of data at the end of clinical trials and subsequently be involved in the writing of final medical study reports.
  • To assist with the writing of any other medical or study reports that may be required, e.g. with relation to investigations, results obtained or study methodology.

 Medical writing

  • To contribute to the writing of Study Operations Manuals for upcoming studies and update as appropriate during the conduct of ongoing studies.
  • To write Patient Information Leaflets/Informed Consent Forms for planned clinical studies.
  • To review study protocols and to participate in the generation of study protocols as required.
  • To actively contribute to the review and updating of RPL’s SOPs and produce UPIRs when required.
  • To assist in the production of proposals for future studies, which may include presentations to clients.

Regulatory work

  • To write relevant sections of Patient Information Leaflets/Informed Consent Forms.
  • To review and contribute to the development of Investigator’s Brochures when required.
  • To review and implement recommendation from scientific advisory meetings into relevant study documents in preparation for submission.
  • To participate in discussions with scientific and other experts in preparation for regulatory submissions.
  • To liaise with sponsor’s in preparation for submissions to regulatory bodies.
  • To participate in preparing submissions to the Ethics Committee.
  • To present the applications at the Ethics Committee meetings.
  • To act upon REC opinion letters and amend documentation as necessary in preparation for resubmission.
  • To participate in preparing submissions to the MHRA.
  • To respond to MHRA opinions as required and prepare any necessary re-submissions.
  • To assist with the preparation for regulatory bodies’ external audits and accreditation inspections, and to assist with the conduct of these inspections.

Management responsibilities

  • To manage the doctor’s rota and ensure, with the Medical Director and/or HR, that the medical department is staffed appropriately at all times.
  • To manage the day-to-day functioning of the clinic alongside the Operations department, ensuring it is efficient and productive.
  • Through acting as the lead study physician for named studies, take responsibility for supervising that study in the clinic, liaise with the Principal Investigator, other departments and the sponsor to ensure the study is well-run and successful.
  • To ensure all Incident Reports, if required, are thoroughly completed and contribute to any process improvement steps that arise from such events.
  • To participate in Quality Improvement (QI) activities.
  • To act as an appraiser of other doctors in the department and conduct yearly revalidation appraisals (in compliance with GMC or NHS England guidance).

Education and training

  • To be up to date with all relevant training and examinations at all times, and maintain delegation for all relevant study-specific tasks.
  • To participate in further education in Pharmaceutical Medicine and Clinical Pharmacology.
  • To continue with personal and professional development.
  • To participate in annual appraisals and the revalidation process (this can be done via PMST if preferred).
  • To contribute to the training of clinical staff members and other doctors in the medical department.
  • To assist in preparing new research physicians for internal competency-based examinations.
  • To act, when appropriate, as a mentor to new research physicians joining the department.

Publications

  • To prepare abstracts, posters and papers for publication.
  • To review of relevant research papers in preparing to write new papers for publication.
  • To review data and results being reported.
  • To write papers or sections of papers for eventual publication.
  • To prepare and give oral presentations at scientific meetings.

LOCATION

London, full time onsite

DURATION

Permanent

SALARY

Very competitive salary + attractive benefits.   

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

  • If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 20 3928 8388 or e-mail on jsmith@planet-pharma.co.uk
  • If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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