Decentralized Medical Affairs Associate

SUMMARY:

The Decentralized Medical Associate plays a pivotal role in supporting the medical oversight and operational integrity of decentralized and virtual clinical studies. This position directly assists the Central Principal Investigator (PI) in meeting regulatory requirements for oversight and compliance, facilitates communication with local and central teams, and ensures the proper tracking and documentation of medically relevant trial activities. This role combines and requires strong organizational, attention to detail, technical, and communication skills to complete project related tasks in a fast-paced research environment.

ESSENTIAL DUTIES:

Working with Chief Medical Officer and Medical Affairs team to operationalize decentralized clinical trials to ensure participant safety and data integrity. 

Key Responsibilities:

1. PI Oversight Support & Regulatory Compliance

• Support the Principal Investigator by tracking and maintaining all documentation required to demonstrate PI oversight in line with FDA and GCP standards.
• Maintain and organize the Investigator Site File (ISF), with specific attention to communications, meeting summaries, follow-up actions, and documented outcomes related to PI oversight.
• Coordinate communications and interactions between the PI and local Sub-Investigators (Sub-Is), site coordinators, and other study staff to ensure alignment with PI directives and study protocol.

2. Medical Metrics and Reporting

• Assist in gathering and compiling medical-related data and metrics as requested by study sponsors.
• Ensure the accuracy and completeness of all medical documentation required.
• Assists with coordination of team meetings, attends meetings, and prepares accurate meeting minutes and action items.

3. Cross-Functional Coordination

• Collaborate closely with the Project Manager at the project level to align on timelines, deliverables, and documentation processes.
• Serve as a key liaison between clinical operations and medical teams to ensure smooth execution of decentralized study activities.

4. Medical Data Clarification

• Work closely with RN Coordinator team to communicate with GI, pathology, and surgical sites to obtain clarification on relevant medical reports, including colonoscopy, pathology, and surgical documentation.
• Facilitate timely resolution of data queries and ensure consistency across medical documentation sources.

5. Medical Adjudication Support

• Manage communications and documentation related to the medical adjudication process, including coordination with PI, RN Coordinators and sponsor medical monitor/pathologist. 
• Maintain records of adjudication decisions and related correspondence for medical teams eCRF guidance document.

Other duties as required and/or assigned. 

QUALIFICATIONS:

Strong understanding of medical terminology and able to communicate this information to others at their level of understanding.

Knowledgeable about FDA, ICH-GCP, and regulatory expectations for PI oversight.

Very strong organizational skills with keen attention to detail and documentation. Able to create structure, understand processes logic and naturally see patterns in systems and data. 

Strong acumen regarding data, metrics, structures, and analysis.

Excellent verbal and written communication skills; ability to interact professionally with physicians, site staff, and sponsor representatives.

Experience with electronic Trial Master File (eTMF) systems and remote communication platforms (e.g., MS Teams, Zoom, CTMS systems).

Ability to work in a dynamic, fast-paced, and evolving clinical environment.

Strong follow through skills and able to manage multiple tasks, projects, and communication flows in a timely manner.

Strong customer service orientation and focus.

Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.

Flexible, proactive, and solution-oriented mindset with a focus on operational excellence.

Strong Excel skills able, to do macros.

High attention to detail and produce accurate work.

Self-motivated, including the ability to work independently to complete tasks, respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.

EXPERIENCE AND KNOWLEDGE:

Minimum 5 years of experience in health care settings.

Able to understand medical

Minimum 4 years of experience in clinical trials, with at least 1 year in decentralized or hybrid trial settings.

Experience with electronic Trial Master File (eTMF) systems and remote is required

Understanding of pathology and GI terminology is a plus.

ENVIRONMENT:

This is a remote position based on the location of the incumbent’s home. This role routinely uses standard office equipment such as computers, printers, copiers, and phones.

Less than 25% travel may be required to support the position’s responsibilities

PHYSICAL DEMANDS:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is required to:

Regularly work at a desk using a computer for prolonged periods.

Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.

Regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.

Frequently stand/walk, grasp objects, and perform lightly/fine manipulation of objects.

Occasionally move safely over uneven surfaces.

Occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 20 pounds.

ADDITIONAL:

Elligo Health Research is a dynamic organization in a rapidly changing industry. Accordingly, the responsibilities associated with this job may change from time to time in accordance with business needs. More specifically, the incumbent may be required to perform additional and/or different responsibilities from those set forth above.

The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are designed only to describe the general nature of the job.

The incumbent must be flexible as there may be workweeks that require more than 40 hours to ensure the position’s expectations and responsibilities are met. 

Elligo Health Research is committed to a policy of equal employment and will not discriminate against an applicant or associate based on his or her age, sex, sexual orientation, gender identity, race, color, creed, religion, national origin or ancestry, citizenship, marital status, familial status, physical or mental disability, handicap, military or veteran status, genetic information, pregnancy or any other category protected under federal, state or local law, regulation or ordinance.