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SSU Project Coordinator

Employer
GSK
Location
Philadelphia, Pennsylvania
Salary
Competitive
Closing date
Aug 18, 2022

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Discipline
Health Sciences, Medicine
Job Type
Other
Organization Type
Pharma
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GSK is seeking to hire a Study Start-Up Project Coordinator (SSUPC)!

In this role, the SSUPC will provide administration, maintenance, and coordination of logistical aspects of country level study start-up activities . This includes the management of the following processes: site feasibility, selection, recruitment planning, training, regulatory package completion and site activation.

This role also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position will primarily work with the local operating company (LOC) Study Start Up Managers and Local Delivery Leads as well as the global Feasibility and Recruitment Planning Managers.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Responsible for managing country and site level feasibility including developing questionnaires, analyzing responses, executing Confidential Agreements and strategizing with local delivery leads and medical team members.
  • Works with key stakeholders to establish regulatory requirements and contracts necessary for start-up.
  • Maintains up to date participating center's information (including all contact details, contracts, and reports).
  • Responsible for preparation, collation, review and tracking of all documentation required for approvals processes (e.g. regulatory, ethics, green light process etc.).
  • Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies.
  • Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
  • Review and provide feedback to management on site performance metrics.
  • Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up
  • Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.
  • Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
  • Transition oversight accountabilities to the LDL and local CSS at the end of the start-up phase
  • May be responsible to oversee the clinical and ancillary supplies vendor(s), preparing and reviewing importation documentation, and logistics.
  • As an active participant of clinical study teams, engage in local study meetings to obtain general knowledge about the study and be responsible for given tasks.
  • Accountable for acquiring/maintaining an optimal level of knowledge of GSK tools and systems to effectively manage them. Is the single point of contact for local study teams for study support questions.
  • Maintain effective communication and working relationships with Investigators, other site staff, above country colleagues and other GSK staff.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's Degree in relevant Scientific field (i.e., Pharmaceutical Industry, clinical operations)
  • 2 years' work experience in the clinical research field
  • Expert working knowledge of the ICH and FDA guidelines and of the IRBI/IEC regulations
  • Experience working with cross functional teams
  • Experience working with computers and various applications (i.e., Microsoft Office) required
  • Experience in written and verbal communication in English and local language required
  • Experience collaborating and organizational skills with ability to interact well with all levels of management and staff


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • 2 years' work experience with investigator start-up documents and investigative sites
  • Demonstrated ability to multitask and prioritize work based on own judgment
  • Self-motivated with ability to work, solve problems and make decisions unsupervised


Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.


*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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