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Clinical Research Project Lead Jobs in Indiana (NOW HIRING)

DaVita

$23.50 - $31/hr

They take ownership of results and instill accountability in those they lead. They are driven ... Responsible to deliver or exceed project enrollment targets for clinical research studies at their ...

Elanco

Project Lead Data Manager

Indianapolis, IN · Hybrid

$49.50 - $67/hr

Project Lead Data Manager As a Project Lead Data Manager, you will serve as a technical authority ... A minimum of 5 years in Clinical Data Management, with proven experience supporting global Research ...

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Clinical Research Project Lead information

What is a clinical research project lead?

A Clinical Research Project Lead is a professional responsible for overseeing and managing clinical research studies to ensure they are conducted efficiently, ethically, and in compliance with regulatory standards. They coordinate study timelines, budgets, and resources, and act as a primary point of contact between research teams, sponsors, and regulatory bodies. Their duties also include monitoring study progress, resolving issues, and ensuring proper documentation and reporting. This role is critical for the successful execution of clinical trials and the advancement of medical knowledge.

What are the key skills and qualifications needed to thrive as a clinical research project lead?

To thrive as a Clinical Research Project Lead, you need expertise in clinical trial management, regulatory compliance, and a background in life sciences or a related field, often supported by a bachelor's or advanced degree. Familiarity with electronic data capture (EDC) systems, project management tools like MS Project, and certifications such as PMI or ACRP are highly valuable. Strong leadership, organizational skills, and effective communication help manage multidisciplinary teams and ensure project milestones are met. These competencies are essential for delivering high-quality research outcomes while maintaining regulatory standards and efficient project execution.

How does a clinical research project lead typically collaborate with cross-functional teams during a study?

A Clinical Research Project Lead works closely with a variety of cross-functional teams, including clinical operations, data management, regulatory affairs, and biostatistics. They coordinate meetings, facilitate communication, and ensure all teams are aligned with the study's timelines and goals. Effective collaboration is essential for resolving issues quickly, maintaining regulatory compliance, and keeping the study on schedule. Project Leads often act as the primary point of contact, fostering teamwork and ensuring that all stakeholders are updated on progress and changes.

What is the difference between Clinical Research Project Lead vs Clinical Research Coordinator?

AspectClinical Research Project LeadClinical Research Coordinator
CredentialsBachelor's or higher in life sciences, often with project management experienceBachelor's degree in health sciences or related field, often with certification
Work EnvironmentLeads multiple projects, manages teams, oversees study progressSupports study activities, manages participant recruitment, data collection
Employer & Industry UsagePharmaceutical companies, CROs, academic research centersHospitals, clinics, research institutions
Search & Comparison IntentUnderstanding leadership and project management roles in clinical researchFocus on study coordination and participant management

The Clinical Research Project Lead typically oversees multiple clinical studies, manages teams, and ensures project milestones are met. In contrast, the Clinical Research Coordinator handles day-to-day study activities, participant interactions, and data collection. Both roles are essential but differ in scope, responsibilities, and level of leadership within the clinical research process.

What cities in Indiana are hiring for Clinical Research Project Lead jobs?

Cities in Indiana with the most Clinical Research Project Lead job openings:

Clinical Research Coordinator

Indianapolis, IN

Innovative Hematology, Inc.
See more jobs at Innovative Hematology, Inc.external

$23.25 - $30.75/hr

Full-time

Re-posted 13 days ago

Job description

About IHI

At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.

What You Will Do

As a Clinical Research Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols.

The Opportunity

  • Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.
  • Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI.
  • Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.
  • Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care.  Explain informed consent for each study participant; document refusals according to protocol.
  • Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors.
  • Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.
  • Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
  • Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
  • Participate in internal quality assurance; review monitor reports for trends across studies.

Requirements

  • Minimum Associate's degree in related field required.
  • Minimum 1 year of related experience required.
  • Valid Indiana Driver's license and automobile insurance required.
  • All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role. 

Benefits

IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package. 

IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics. 

IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services. 

IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more. 

Innovative Hematology, Inc. is an Equal Opportunity Employer. 

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