PART TIME Clinical Research Coordinator
Actalent
** This is a PART- TIME ROLE ( approx 10 hours per week)**Clinical Research Coordinator
The Clinical Research Coordinator will provide leadership and insight at the site level, specifically for aligned studies. This role requires flexibility, with patient enrollment averaging closer to 10 hours per week but potentially flexing up to 20 hours per week.
Responsibilities
+ Collaborate with clinical operations staff to perform study feasibility, operations planning, site management, and field monitoring.
+ Support and assist in the development of all study-related manuals and documentation, including the Study Manual of Operations, Master ICF Template, Monitoring Plan, and various regulatory documents.
+ Establish and maintain excellent working relationships with external stakeholders such as Investigators, Study Coordinators, and other site staff, as well as internal stakeholders to meet recruitment targets and deliver high-quality data on time and within the study budget.
+ Ensure all Adverse Events (AE), Serious Adverse Events (SAEs), and Product Quality Complaints are reported within required timelines and documented appropriately.
+ Maintain and update trial management systems.
+ Attend and participate in Investigator Meetings as needed, and possibly schedule and conduct country-specific investigator meetings as directed by the study team.
+ Perform field monitoring independently, including qualifying site assessments, initiation, interim, and closeout visits.
+ Build collaborative partnerships with other Clinical Research Coordinators and provide support as needed.
+ Assist the study team in planning clinical supplies, ensuring the availability of the Investigational Product for site support.
+ Develop strong therapeutic knowledge to support the study team and sites, potentially representing clinical operations on cross-functional teams.
+ Actively contribute to process improvement, training, and mentoring of newer Clinical Research Coordinators.
Essential Skills
+ Bachelor's degree or completion of a Nursing Program at the Bachelor's level (RN).
+ A minimum of 5 years of pharmaceutical drug development and clinical operations experience in site management and monitoring.
+ Knowledge of the drug development process, Good Clinical Practices (ICH-GCP), GDP, SOPs, and compliance with FDA Code of Federal Regulations.
+ Strong computer skills in appropriate software applications and related clinical systems.
+ Strong written and oral communication and organizational skills.
+ Flexible mindset with the ability to work in a fast-changing environment.
Pay and Benefits
The pay range for this position is $40.00 - $45.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Philadelphia,PA.
Application Deadline
This position is anticipated to close on May 9, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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