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28 days old

Study Responsible Physician

Kelly Services
Philadelphia, PA 19133
  • Jobs Rated
    102nd
**Study Responsible Physician**


**Responsibilities:**


+ Assist in the creation of regulatory/submission documents

+ Act as a support to and resource for Medical Affairs

+ Assist in writing/review of abstracts/manuscripts

+ Assist in creation of Investigator Brochure

+ Interact with clinicians/experts (e.g. Advisory Boards) as necessary


**Pre-Trial Activities:**


+ Contribute to the design of the trial through creation of the Protocol Elements Document (PED)

+ Contribute to the development of the Clinical Trial Protocol and its review within the specified timelines

+ Contribute to the development and review of the trial specific risk benefit document as applicable

+ Contribute to investigator meeting presentations/site initiation visits as applicable

+ Review the Trial specific Master Informed Consent Form within the specified timelines

+ Contribute to responses to trial related questions from IECs/IRBs

+ Review the Statistical Analysis plan (SAP) within the specified timelines

+ Review the Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) charter in consultation with a physician

+ Review and approve protocol specific protocol deviation (PD) criteria list

+ Develop & agree on the Safety Management plan in consultation with a physician

+ Input on SOW for central lab, central ECG and other vendors as applicable

+ Review of eCRF and other data collection tools

+ Give input in site selection

+ Provide trial/compound specific training to monitors


**During Trial Activities:**


+ Answer trial related medical questions and interact with investigators/sites, CROs, etc.

+ Review medical aspects of screening and ascertain suitability of subjects as needed

+ Review of Data and Safety Monitoring Board (DSMB) reports as applicable

+ Perform medical review and safety analysis of clinical trial subjects; including periodic completion of the Safety Management Plan for individual trials

+ Assist in determination whether new safety information requires an Amendment to the CTP and/or ICF

+ Review and approval of AE coding and concomitant medication lists

+ Review AEs of Special Interest

+ Assess Protocol Violations

+ Contribute to Trial Team Meeting on an agenda driven basis

+ Review SAEs in real-time and provide input of the assessment as needed

+ Contribute to the development and review of protocol amendments

+ Review trial specific ICF for updates based on CTP amendment, IB amendment or updated IB


**Post-trial activities:**


+ Review PV listings

+ Assist in preparation of the safety part of Top Line Results presentation

+ Review narratives

+ Assist in creation and review of Clinical Research Report and approve if applicable

+ Assist in ADR review and adjudication

+ Assist in labeling process

+ Contribute to presentation of trial results


**Requirements:**


+ University degree MD

+ Preferably experienced in drug development (e.g. Project Management, Pharmacovigilance, Medical Affairs, Pharmacokinetics, Clinical Pharmacology)

+ Preferably experience in clinical development (e.g. medical dept. or operations)

+ Good Communication skills

+ Ability to effectively work as part of a team

+ Conflict handling skills

+ Presentation skills

+ Organizational skills


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Categories

Jobs Rated Reports for Physician

Posted: 2022-04-20 Expires: 2022-05-26

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Study Responsible Physician

Kelly Services
Philadelphia, PA 19133

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Physician
102nd2019 - Physician
Overall Rating: 102/199
Median Salary: $211,780

Work Environment
Very Poor
207/220
Stress
High
168/220
Growth
Good
51/220
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