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Job Title: Clinical CoordinatorJob Description

Acts as a liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on all regulatory issues and changes within the protocol. In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study. Reviews study with principal investigator and/or clinical research nurses to create a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator. Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversees subject enrollment to ensure that informed consent is properly obtained and documented. Coordinates research activities including scheduling laboratory tests, radiology testing, and other medical exams as required. Works with the study team to draft/create study-specific study orders, billing templates, and study calendars as necessary. Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols. Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. Registers protocol patients with appropriate statistical centers as required. Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts. Acts as principal investigator's representative as appropriate, which may include communicating with sponsors and their representatives, the IRB, and other medical personnel. Along with clinical research nurses, maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required.

Responsibilities

• Acts as liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on regulatory issues and protocol changes.

• Collaborates with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluate potential competition with other protocols.

• Reviews studies with the principal investigator and/or clinical research nurses to create a budget outlining standard of care and research costs.

• Finalizes budget drafts with the budget coordinator.

• Evaluates proposed study protocols for factors such as sample collection processes, data management plans, and potential subject risks.

• Oversees subject enrollment to ensure proper informed consent is obtained and documented.

• Coordinates research activities, including scheduling laboratory tests, radiology testing, and other medical exams.

• Works with the study team to draft/create study-specific study orders, billing templates, and study calendars.

• Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols.

• Monitors all study activities to ensure compliance with protocols and relevant local, federal, and state regulatory and institutional policies.

• Registers protocol patients with appropriate statistical centers as required.

• Tracks enrollment status of subjects and documents dropout information.

• Acts as the principal investigator's representative when necessary, including communicating with sponsors, the IRB, and other medical personnel.

• Maintains accurate, complete, up-to-date records on each protocol and patient in the clinical trial management system and all other systems as required.

Essential Skills

• Experience as a medical assistant, LPN, or in clinical research.

• Strong understanding of clinical research protocols and regulatory requirements.

• Ability to collaborate effectively with a multidisciplinary team.

• Strong organizational and time management skills.

• Excellent communication skills, both written and verbal.

• Attention to detail and accuracy in record-keeping.

Additional Skills & Qualifications

• Familiarity with clinical trial management systems.

• Experience in budget creation and management.

• Understanding of sample collection processes and data management plans.

Work Environment

The Clinical Coordinator will thrive in a people-first environment that prioritizes career growth opportunities, tuition assistance, and resources that support wellness, education, and financial well-being. This role includes paid time off, comprehensive health benefits, and a supportive, inclusive culture. Advanced technology is used to support the team and enhance patient care.

Pay and Benefits

The pay range for this position is $50000.00 - $54454.00

• Hackensack Meridian Pascack Valley Medical Center is a 128-bed, full-service, acute-care community hospital with a new emergency department, a state-of-the-art maternity center, a women's imaging center, and an ICU.

Workplace Type

This is a fully onsite position in Hackensack,NJ.

Application Deadline

This position will be accepting applications until Dec 27, 2024.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.