FOCM Welcomes New Members

On a warm, pleasant evening in October, the 1st day of the month to be precise, a significant event in FOCM history occurred; 4 new members received their cards.

I was in the RTP area to attend the Arena International Clinical Trial Supply Southeast meeting and hosted a FOCM networking event at the Sheraton Imperial Lobby Bar.

Attending that night were long time* members as well as first timers+.  As best I can recall, the following people were there: Michael Williams*, Kris Gustafson*, Mike Burrows*, Rosina Pavia*, Paul Oldfield*, Tim Sauls*, David Holland, Carolyn Waff+, Lauren Sherwood, Israel Bocanegra+, Shae Wilkins* (traveled the farthest) .

Receiving their membership cards were: Lauren Sherwood, Carolyn Waff, David Holland and Israel Bocanegra.  As you can expect, emotions ran high during the card ceremony, with many people wiping tears from their eyes.  The look of sheer joy on their faces the moment they realized they’d completed the sometimes long, sometimes short, but neverthless arduous and rigorous initiation process.

Carolyn Waff
David Holland
Lauren Sherwood

 

 

 

 

 

Israel Bocanegra

 

 

 

 

 

Happy Inductees – 10/1/2018

Job Opportunity for Oncology Health Care Clinician

Am helping a FOCM member find a candidate for the position described below.  Additional information: basically need a current/recent oncology nurse or NP that is also good at knowing when data regarding patient volumes from EMR queries are likely inaccurate. It’s a key role that is critical to our meeting our deliverables… I think the perfect person has that oncology nursing background, but maybe left 2-3 years ago to join one of the CROs as a CRA or PM.

Job Title: Manager, Nursing Informatics – Oncology
Reports to Vice President, Clinical Operations
Location: Raleigh, NC

Job Purpose
Utilize knowledge of oncology patient care to support proposal development and clinical trials via thorough curation, analysis, and interpretation of EMR data housed in data warehouse.

Duties and Responsibilities
1. Develop clinical trial enrollment projections for bids
2. Assess impact of amendments to ongoing clinical trials, including revised projections
3. Collaborate with IT to build accurate data queries for awarded clinical trial projects and to modify queries as necessary on an ongoing basis
4. Review medical records of patients identified by data queries as likely matches to a clinical research, and determine eligibility.
5. Maintain and manage “watch list” of those patients that are not currently eligible but may be in the future based on disease progression, resolved comorbidities, etc., to ensure timely enrollment when appropriate.
6. Communicate specific patients’ eligibility and logistical information (e.g., date/time of next appointment, exam results, etc.) to onsite clinical research staff
7. Track progress/actions in study applications
8. May supervise other data-oriented positions within the Clinical Operations department
9. Handle other duties as assigned.

Minimum Qualifications:
• BA/BS degree preferred; equivalent combined education and experience will be considered
• Understanding of clinical research fundamentals
• Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines, required

Experience:
• Three (3) years’ experience delivering oncology care delivery as a nurse, nurse practitioner, or other healthcare provider. Clinical research experience strongly preferred, whether as a study coordinator or in an operational role at a CRO or pharma company

Required Competencies/Knowledge, Skills and Abilities:
• Functional knowledge of patient pathways in oncology
• Functional knowledge of clinical research workflow and regulations.
• Ability to organize and analyze data to derive reasonable interpretations and conclusions
• Ability to quickly learn new software applications.
• Strong written and verbal communication skills.
• Strong organizational skills, including ability to manage multiple deliverables across multiple projects.
• Excellent office productivity skills, especially with MS Word and Excel, as well as strong familiarity with clinical trials management software.
• Adaptability and flexibility.
• Ability to complete tasks independently, accurately, and within compressed timelines.

Working conditions
Day shift with standard working hours (8AM – 5 PM); corporate office and/or home office environment with regular computer and phone usage. Minimal travel expected (less than 5%) after initial training/onboarding.

Direct reports
This position may have direct reports depending on company growth and needs.

LaunchBio NC Networking

LaunchBio (LaunchBio) holds events on the first Thursday of the month in Durham, NC.  They are held in the Chesterfield Building in the downtown area.  The building was formerly a cigarette manufacturing building.  It has now been converted and there is incubator lab space for drug discovery and development.

It is a great opportunity for networking with people involved in the clinical research industry.  Here I am enjoying a Durty Bull Lager beer and conversation with Peter Weiman and David Holland (they’re drinking the IPA that was being served).

LaunchBio_August_2018_Web-10

FOCM New Members and DIA 2018

FOCM was busy before and at the DIA convention in Boston in June.  FOCM along with Zymewire, Investigator Support Services, Kwipped and DataMatrix sponsored the 2nd annual Sunday night networking event before DIA exhibits opened.  In the exhibit hall, FOCM gave its seal of approval to several vendors, assisTek being one.  Unfortunately, the Arizona State Sun Devil hand sign snuck into the picture.  In the shadow on the table, it appears to be a weapon of some kind.

Clinical Reconnections Event Hosts
assisTek

 

 

 

 

 

 

 

At the recent annual Drug Information Association (DIA) meeting held in Boston last month, two outstanding individuals completed the grueling probationary period, thorough background checks and initiation process. Please join me in welcoming Andrew Suri and Megan Carson to FOCM. As others who have received their membership cards, the ceremony itself can be emotionally draining. This was no exception, the sheer joy on their faces tells the story.

Andrew is Director of Business Development for Clinogix.  Megan is Assistant Project Manager at assisTek.

Andrew Suri
Megan Carson

Job Finding Assistance Request

A dues-paying FOCM Network member, Carrie Gallagher has requested the assistance of the network in connecting her son, Patrick Gallagher to opportunities of employment in the Raleigh-Durham area. The strength, breadth and depth of the FOCM network to help in this endeavor is being sought out.

Patrick wants to get into the video game industry and has recently applied at Red Storm Entertainment, Boss Keys and Epic Games. For FOCM Members in the Raleigh/Durham area: does anyone know someone at these or other video game industry companies that might be willing to help Patrick get an informational interview/meeting. He’s just looking to speak with someone and knows that the rest is up to him.
Patrick has taken classes in scientific and technical visualization, game art and design, is proficient in 3DS Max and builds his own computers. He has some coding experience but isn’t certified just yet.

Patrick has worked continuously since he was 16. He is hard working, smart, and nice (his mother’s words and I have met him and agree with her). He’s done very well at every job he has held; always given more responsibility and is well liked by his colleagues. He is ready to move from a job to a career.

Any help would be greatly appreciated.
Patrick’s Resume

FOCM Networking Meeting Minutes March 12, 2018

Report filed from Outpost RTP:

March 12, 2018

It was a bitterly cold and snowy night that caused all but the bravest souls to stay in their warm homes.  Only a select few dared to venture out into the third major winter storm in March.

FOCM members are nothing if not brave, courageous, oh and, thirsty, let’s not forget that.  So there we were on March 12, had previously arranged to have this event at a location which will now remain nameless since they closed and didn’t let me know.  A quick decision was needed and made.  With no time to spare a note was sent out stating we would meet at Mez.

First to arrive at the closed meeting site was Pippa Wilson of Barrington James, second to arrive was Kathleen Finn of Barrington James, third to arrive was Bernie Linner with West Coast Clinical Trials.  We then headed to Mez where we met up with the intrepid (yes, I used dictionary.com) FOCM members (Drew Harrison, Steve Caravaglio, Derrick Ferrar, Carol Miller (photo taker), Chad Pollio, Brooks Satterfield and Kasey Karr (not pictured; arrived late, but made up for it by staying late).  FOCM NEVER cancels its events due to weather! (of course, FOCM reserves the right to change its rules at any time.)

FOCM Winter Storm Warriors

FOCM at Global Clinical Supplies Conference

The month was April, the year 2016, the event: the #1 clinical research industry’s clinical supplies conference – Global Clinical Supply Group.  Several important events happened with photographic evidence to support it.

It was my honor to give a FOCM membership card to one of my favorite co-workers of all-time, Roxann Pinguelo.  Is she thrilled or what?

Roxann Pinguelo

FOCM also welcomed Ryan Jarvis to the organization and Russ Brierley and Renee Brown were on hand to witness these ceremonies.

Ryan Jarvis
Russ Brierley, Ryan Jarvis, Roxann Pinguelo, Renee Brown

FOCM Members at Wilmington NC Event

Here’s an interesting item about FOCM that I just realized comes from my having grown up in a small town in Arizona – if there’s a party in town – join it! You may call it crashing it, but in Yuma, AZ, if there was a wedding reception in town, regardless if you were invited, you went to it.  So in that vein, when I organize Wilmington Pharma/Bio/CRO Networking Events in Wilmington, NC, it’s an open call for all FOCM members.  While in this case they do belong to the Pharma/Bio/CRO industry, they do also belong to FOCM.

Kris Klein, John Peterson, Wendy Revenaugh, Gayle Grandinetti and Steve Simpson

FOCM World of Beer Networking Event

I am determined to catch up with my backlog of posts and pictures.  It was March 15, 2016 at World of Beer in Cary, NC where a FOCM Networking Event was held.  It was the night before Arena International’s Outsourcing in Clinical Trials Southeast meeting.

Quite a good turnout and FOCM membership cards were given out to deserving members.  Attendees included: Chad Pollio, Lisa Campbell, Bernie Linner, Jeff Hudak, Vince Hoefling, Constance Hopkins, Deb Carfagno, Mark Paul and a colleague, Denee Oakley, Peter Payne, Paula Heyer, Jennifer with Acurian, Dana Edwards and a colleague, Kim Martinez, Erin Tabet and a colleague, Rosina Pavia, Michelle Jacobson, Sue Joor, Paul Eisenmann, Brian Langin, Jon Gardow, Diane Romick, Alison Greenwood, Laura Peters, Mike Markowitz, Garrett Smith, Chris Ramm, Pippa Wilson, Paul Oldfield, Breyona Fenner and two that I only have down as ‘knows Ken Billard’ and ‘Brit TRX guy’.

Diane Romick
The Crowd
Sue Joor, Michelle Jacobson
Breyona Fenner
Sue Joor
Deb Carfagno, Chad Pollio

FOCM attends Site Solution Summit

I will be attending Site Solution Summit in Boca Raton, October 6 – 8, 2017.   I am appreciative of being asked to faciliate one of the breakout sessions on Saturday.   More than likely I’ll organize a happy hour for October 7.

Site Solution Summit 2017

Site Solution Summit Break out Session