Megan Conley
Angier,NC
Summary
A Senior Site Start-Up Associate with experience spanning over 10 years within the CRO and IRB environment. Key experiences are within Neurology, Rare Disease, Homology, Dermatology, Analgesia, and General Medicine including adult and pediatric populations.
Results-driven professional equipped with background in supporting operational workflows and enhancing team productivity. Proven track record in streamlining processes and fostering productive collaboration. Committed to delivering high-quality results and adapting to dynamic environments with strong communication and problem-solving abilities.
Overview
10
10
years of professional experience
Work History
Senior Start-Up Associate
Premier Research
2024.04 - Current
- Lead Site Start-Up Associate who managed five Site Start-Up Associates on a large analgesic schedule I-controlled substance study with greater than 150 sites.
- Managed two studies with initial IRB submissions in parallel with short timelines across the US and Canada.
- Mentored new Site Start-Up Associates on Premier processes and start-up workflows including providing guidance on Premier SOPs, completing central IRB submissions, reviewing start-up documents and using internal systems such as Remarque for tracking.
- Assisted team members by performing first and second ICF reviews for several different studies and therapeutic areas.
- Completed timely review of all required site start-up documents across all studies to ensure all Sponsor timelines were met.
- Managed a company initiative for a central IRB processing guide and workflow.
- Subject matter expert within SSU for federally funded studies, schedule I-controlled substance studies, and central IRB processes.
- Provided regulatory guidance to Sponsors regarding requirements for the central IRB and site start-up documents.
Site Start-Up Associate II
Premier Research
2023.04 - 2024.04
- Successfully managed two Neurology studies in SSU with tight timelines and more than 15 sites each in parallel.
- Provided regulatory guidance to Sponsors regarding requirements for the central IRB and site start-up documents.
- Mentored new Site Start-Up Associates on Premier processes and start-up workflows including providing guidance on Premier SOPs, completing central IRB submissions, reviewing start-up documents and using internal systems such as Remarque for tracking.
- Assisted team members by performing first and second ICF reviews for several different studies and therapeutic areas.
- Completed timely review of all required site start-up documents across all studies to ensure all Sponsor timelines were met.
Site Start-Up Associate I
Premier Research
2021.07 - 2023.04
- Successfully managed more than 50 sites on a large, federally funded Neurology study.
- Assisted team members by performing first ICF reviews for several different studies and therapeutic areas.
- Completed timely review of all required site start-up documents across all studies to ensure all Sponsor timelines were met.
- Managed a central IRB vendor requiring bi-weekly meetings to talk through several corrective actions required to ensure the best quality deliverables were received.
- Provided regulatory guidance to Sponsors regarding requirements for the central IRB and site start-up documents.
IRB Analyst - Study Start-Up
WCG IRB
2018.12 - 2021.07
- New study point of contact for several clients across several therapeutic areas.
- Reviewed and edited all new study ICFs assigned for regulatory completeness according to SOPs.
- Attended Board meetings for all new studies assigned and designated as Board Secretary for 1-2 Full Board meetings per week.
- Trained new employees on Pre-Board and Post-Board processes which included review of protocols for Expedited vs. Full Board requirements, ICF editing, reviewing conditional approval responses and finalizing full approval documents.
- Took part in several company initiatives including assisting and training of all employees after the Western IRB and Copernicus Group merger on the several different internal data systems.
- Attended trainings for obtaining CIP.
- Lead the IRB’s correction team in processing and managing of required corrections to study and site level approvals.
IRB Operations Analyst - Safety, Study Status and Study Management
WCG IRB
2016.03 - 2018.12
- Client point of contact after initial Study Start-Up through end of study for all assigned studies.
- Processed SUSAR reports in a timely and thorough manner as received.
- Reviewed and processed all Change in Research submissions as assigned including protocol amendments, updated protocol support documents, updated recruitment and subject materials, changes in research locations, and ICF revisions.
- Processed Continuing Review Reports and Closures at the study-level and for sites as assigned.
- Participated in change controls and process improvements within the company including the creation of a correction team.
IRB Operations Coordinator - Study Start-Up
WCG
2015.12 - 2016.03
- Successfully assisted with reviewing and processing new Canadian studies as assigned across several different therapeutic areas.
- Reviewed and processed Board Meeting Agenda and Meeting Minutes as assigned.
- Assisted clients Canadian-specific regulatory questions related to initial submissions.
Education
High School -
Athens Drive High School
Raleigh, NC2006-01
Skills
- Customer service
- Time management
- Attention to detail
- Computer skills
- Decision-making
- Complex Problem-solving
- Relationship building
- New hire training
- Teamwork and collaboration
LANGUAGES SPOKEN
English / Fluent
PUBLICATIONS AND ABSTRACTS
Not applicable.
THERAPEUTIC EXPERIENCE
- Therapeutic Area & Phase
- Analgesia NA
- Phase III - Chronic Low Back Pain
- Dermatology NA
- Phase I - Atopic Dermatitis
- Phase III - Dermatitis
- Endocrine/Metabolic NA
- Phase I/II - Mucopolysaccharidosis (Rare Disease)
- Phase I/II - Thyroid Disorder (Rare Disease, Pediatrics)
- Genetics/Hereditary NA
- Phase I/II - Phenylketonuria (PKU) (Rare Disease)
- Infectious Disease NA
- Phase N/A - Coronaviruses and Acute Respiratory Syndromes (Pediatrics, Device)
- Neurology NA
- Phase III - Alzheimer's disease
- Oncology NA
- Phase N/A - Colorectal
- Phase I/II - Solid Tumors (Pediatrics)
- Psychiatry NA
- Phase II - Drug/Alcohol Dependency
- Phase III - Social Anxiety Disorder
BIOGRAPHY
- Megan Conley is currently a Senior Start-Up Associate in the Study Start-Up department. She prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities’ submissions. She is responsible for quality deliverables and makes sure submission and approval timelines are being adhered to strictly. Previously, Megan worked as a Site Start-Up Associate II and I for Premier Research and was able to fulfill all duties associated for those roles. She held the SSUA I position for about two years and the SSUA II position for year. Prior to that, Megan worked for WCG IRB for five and half years holding the positions of IRB Analyst, Operations Analyst and Operations Coordinator. She has experience working in several different departments within the IRB including Study Management, Safety, Study Status, and Study Start-Up.
- In June of 2010, Megan completed the Certified Nursing Assistant Recertification Program through Johnston Community College in Smithfield, North Carolina. Megan also briefly attended the University of North Carolina at Charlotte in 2006/2007 and completed general course work towards a BSN in Nursing. Lastly Megan graduated from Athens Drive High School in 2006 and received her diploma with Honors.
- At Athens Drive High School Megan was a Medical Science Academy member through which she obtained her original Certified Nursing Assistant Certification and her EMT-Basic License. She was also a member of the National Technical Honor Society.
Timeline
Senior Start-Up Associate
Premier Research
2024.04 - Current
Site Start-Up Associate II
Premier Research
2023.04 - 2024.04
Site Start-Up Associate I
Premier Research
2021.07 - 2023.04
IRB Analyst - Study Start-Up
WCG IRB
2018.12 - 2021.07
IRB Operations Analyst - Safety, Study Status and Study Management
WCG IRB
2016.03 - 2018.12
IRB Operations Coordinator - Study Start-Up
WCG
2015.12 - 2016.03
High School -
Athens Drive High School