Project Coordinator - Medical Affairs
General Summary
This position is responsible for internal execution of project work in the Medical Affairs Division under the direction of an assigned Project Manager and/or Study Director. Individuals in this role may interact with assigned Subject Matter Expert, Study Director, and Project Manager to effectively execute large government and/or commercial studies. A project coordinator may be responsible for independently performing delegated tasks and procedures involving human subjects research. Training will be provided for the position's key responsibilities. Position works closely with assigned project team members and related management for studies.
Essential Duties & Responsibilities
- Assists in drafting protocols, amendments, and departmental notifications for review/editing by the project manager/study director; formats protocols for correct grammar, punctuation, consistency of format and style, and adherence to regulatory requirements and contract language.
- Reviews SOPs associated with study conduct and incorporates language into the protocol describing procedures or processes when all aspects of the SOPs are not followed.
- Assists in the implementation of the study protocol and SOPs through screening and enrolling individuals as required.
- Reviews contract and associated milestones (e.g., enrollment, retention, and other metrics) for use in execution of studies; manages milestone tracking with the project manager and proactively notifies project manager/study director of issues.
- Aids in identifying and incorporating exceptions to GCP conduct into GCP study protocols as applicable (e.g., systems/processes not validated).
- Assists in creating and maintaining the study file (electronic) and/or study binders (hard copy)
- Distributes study protocols, amendments, and departmental notifications; prepares/reviews data collection systems/forms as needed; schedules and assists with conduct of pre-study meetings.
- Submits protocols, study records, and applicable data/reports to IRB for review; manages and coordinates completion of audit responses under the direction of the Project Manager/Study Director.
- Works closely with department leadership to ensure project work is scheduled and resourced appropriately to meet timelines.
- Tracks progress of studies to ensure timely execution of activities.
- May submit requisitions for subcontractors.
- May communicate and approve purchase requisitions of study specific materials.
- May provide coverage for client facing activities when Project Manager is out of office.
- May perform/document study inspections and present findings to Project Manager.
- May prepare data for processing and reporting ensuring quality control is performed and corrections are made.
- Participates in report writing process (e.g., data summaries, and study reports), which may include data table generation, and ensures quality control is performed.
- May conduct periodic compliance reviews or audits with study team and partners to ensure that compliance procedures are followed.
- Reviews project expenditures in conjunction with the Project Manager
- May create corrective and preventative action (CAPA) documents in collaboration with Project Manager, Scientific Subject Matter Experts, Operations supervisors/managers, etc. as applicable.
- Performs other duties as required by their supervisor.
Requirements/Minimum Qualifications
- Bachelor's degree in a scientific field with at least two years of related experience or equivalent combination of education, training, and experience in a laboratory environment.
- Knowledge and ability to use the fundamental concepts, practices, and procedures of the particular field of specialization.
- Knowledge of or the ability to become knowledgeable in GCP procedures/regulations and application of those guides to human subject studies.
- Knowledge of software applications (Windows, Word, Project, Access, Excel, or other software).
- Ability and willingness to learn and utilize specialty software and data applications.
- Effective verbal and written communication skills including correct grammar, spelling, and punctuation.
- Highly detail oriented; possesses good planning, organization, task efficiency, and time management skills.
Essential Functions/Competencies
- Ability to interact with others in a cooperative, persuasive, and tactful manner.
- Ability to read, understand, retain, and apply knowledge of Good Clinical Practices (GCP) and other study requirements.
- Working knowledge of clinical research, research programs, and data management.
- Ability to independently coordinate a varied workload of projects and assignments with multiple priorities in a rapidly changing environment.
- Strong leadership, team building, and problem-solving skills as well as demonstrate ability to work collaboratively with multiple disciplines.
- Ability to type at a reasonable rate of speed and accuracy.
Core Values
Cultivating human connection – putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust.
Operating with precise execution – measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing.
Harnessing relentless curiosity – our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results.
Stewarding a healthy community – implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked.
Job Specific Behaviors
Relationship Orientation – Develops positive relationships by making others feel their concerns and contributions are important.
Continuous Learning – Proactively seeks performance feedback and identifies approaches to improve personal and others performance and learning.
Tolerance for Stress, Ambiguity & Change – Demonstrates flexibility in applying different approaches to changing work demands.
Effective Communication – Creates a team environment in which information flows freely and decision making is based on a win-win philosophy
Compliance – Applies an understanding of keeping legal precedents, policies, and practices to protect the interests of the organization.
Cross-team Collaboration – Ensures integration and cooperation across organizational boundaries.
Attention to detail – Utilizes established monitoring system, records data accurately and timely, and ensures data accuracy.
Planning and Organization – Systematically identifies issues to be addressed and helps plan a course of action for self and others to ensure the accomplishment of specific objectives.
Operational / Technical Excellence – Ensures that work product (whether service or process) enables the organization to deliver on customer's expectations.
Physical Demands
- Ability to perform work utilizing a computer for extended periods of time.
- Ability to sit for extended periods of time without leaving the work area.
- As related to laboratory work (as applicable):
- Ability to stand for extended periods of time without being able to leave the work area.
- Ability to climb ladders and stairs in performing the work.
- Ability to walk for reasonable distances in performing the work.
Certifications, Licenses & Registrations
None required.