Job details
Job type full-time
Full job description
Marinus pharmaceuticals is a clinical stage biopharmaceutical company committed to developing breakthrough therapies to improve the quality of lives of patients and their families as they battle rare and life-threatening diseases.
Based in radnor, pa we are comprised of a team of dedicated and talented professionals, valued for their innovation and commitment to developing new therapies for cns disorders and their passion to make a positive difference in the lives of our patients.
We are currently searching for 3 experienced professionals to join our team as a
SrCra / in-house lead
The in-house lead / srClinical research associate (srIhcra) is an essential member of a clinical development operations team responsible for the execution of domestic and global clinical research studies (ph1 – ph3)The degree of responsibility given to the srIhcra shall reflect their experience, and level of contribution which they can make to the studyThe work will involve clinical operations activities which will be conducted in an office or home-based setting for designated studies as well as some travel to conduct site/client visits or internal team meetings as neededThe srIhcra will be responsible for ensuring quality and integrity of data, monitoring deliverables, and additional study related activities to support the efforts of study team membersActivities will be conducted in compliance with company sops, regulatory standards and applicable guidelines.
Key responsibilities include but not limited to the following:
Ability to lead regional / national cra teams to support resource allocations and accountable for monitoring / data deliverables for assigned studies
Proactively access training needs for field monitors and provide support when needed (e.gCo-monitoring, data deliverables, mentoring, etc.)
Site report review related to more junior staff
Site visit & related site report metric adherence tracking & escalation of missed targets or trends
Contributes to the success of studies to meet short-term objectives & adhere to study schedules
Supports organizational objectives for inspection readiness related to internal and external audits and other regulatory body requests and requirements
Etmf gap reviews
Routine site communication as directed by project lead(s)
Direct interaction with vendors
Support of study builds (eg, edc, etmf/ctms/ract or other) as dictated by project lead(s)
Other business needs that may or may not be project related (eg, department initiatives, sop reviews, etc)
Qualifications:
Minimum of a bachelor’s degree is required
Minimum of 5 years of pharmaceutical/biotech industry experience
Solid understanding of the serious adverse event (sae) reporting, process production of reports, cross reporting, narratives and follow up of saes
Clinical monitoring experience as a traveling cra with onsite monitoring experience including knowledge of monitoring procedures process
Experience in monitoring study sites independently according to protocol monitoring guidelines, sop, and local regulatory guidelines
Thorough knowledge of ich / gcp / cfr guidelines, clinical trial process and understanding of local regulatory requirements (global a plus).
Excellent planning, organization and problem-solving abilities
Excellent communication skills, oral and written
Advanced user of essential computer applications necessary for monitoring clinical trials (e.gMs suite [word, excel, power point], edc, ctms, etmf)
Experience in monitoring ph 1-3 clinical trials
Up to 30% travel is required based upon business needs.
At marinus, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need
Search firm representatives please read carefully
Marinus pharmaceuticals does not accept unsolicited assistance from search firms for employment opportunitiesAll cvs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our companyNo fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in placePlease, no phone calls or emails.
