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Senior Clinical Research Associate Resume
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| Desired Industry: Biotech |
SpiderID: 11484 |
| Desired Job Location: Cary, North Carolina |
Date Posted: 2/28/2007 |
| Type of Position: Contractor |
Availability Date: 3/1/07 |
| Desired Wage: NEG |
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U.S. Work Authorization: Yes |
| Job Level: Experienced with over 2 years experience |
Willing to Travel: Yes, 50-75% |
| Highest Degree Attained: Masters |
Willing to Relocate: No |
Objective:
See skills
Experience:
See skills
Education:
See skills
Affiliations:
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Skills:
Alexander Rae, M.A.
222 Mint Hill Drive
Cary, NC 27519
Tel: 919-699-2779
Fax: 919-363-3069
e-mail: alexmbrae@hotmail.com
Professional Experience
PharmaNet, Cary, NC 10/2005 – 2/2007
Lead Senior Clinical Research Associate
Monitor Investigator sites
Track and maintain budgets, timelines, and project tasks
Organize and present at Investigator’s meetings
Lead team meetings with sponsor and CRAs
Develop protocols and Case Report Forms (CRFs)
Provide training to other clinical research personnel
Prepare status reports for clients and PharmaNet management
Negotiate budgets, prepare contracts and make payments to study sites
Monitor and assist all CRAs on the team, review trip reports, etc.
Monitor, manage and re-supply investigational product for all sites
PharmaNet Project Experience
Phase Indication Description of Responsibilities/Tasks
II Renal Cancer Site management.
II Prostate Cancer Routine monitoring, site management, CRF collections and source document verification.
II & III Melanoma Routine monitoring, site management, CRF collections and source document verification.
II Non small cell lung cancer Monitor Investigator sites, Track and maintain budgets, timelines, and project tasks, Organize and present at Investigator’s meetings, Lead team meeting with sponsor, Develop protocols and Case Report Forms (CRFs), Provide training to other clinical research personnel, Prepare status reports for clients and PharmaNet management, Negotiate budgets, prepare contracts and make payments to study sites, Monitor and assist all CRAs on the team.
PPD Development, Wilmington, NC 3/2002 – 10/2005
Clinical Research Associate II (10/2003 – 10/2005)
Therapeutic areas – oncology (colorectal cancer, acute myeloid leukemia)
Monitored Phase II-IV clinical trial studies
Performed pre-study, initiation, interim monitoring, and close-out visits according to applicable Standard Operating Procedure (SOPs) and FDA guidelines
Responsible for monitoring investigative sites who participated in studies
Participated in the conduct of multi-center clinical research study, reviewed project-related materials, and assisted in Investigator recruitment and literature
Reviewed CRFs for completeness, clarity, legibility, conformity to available source documentation and adherence to protocol requirements
Resolved CRF discrepancies and/or clarifications
Performed drug accountability, reported Adverse Events (AE), and verified completeness of critical documents
Clinical Research Associate I (9/2002 – 10/2003)
Therapeutic areas – ovarian cancer, central nervous system (schizophrenia)
Monitored Phase III and Phase IIIb clinical studies
Assisted in Investigator recruitment and regulatory document collection
Performed pre-study visits according to applicable SOP and FDA guidelines
Monitored Investigative sites
Participated in the conduct of the multi-center clinical research study, and reviewed project-related materials and literature
Reviewed CRFs for completeness, clarity, legibility, conformity to available source documentation and adherence to protocol requirements
Resolved CRF discrepancies and/or clarifications
Performed drug accountability, reported Adverse Events (AE), and verified completeness of critical documents
Clinforce, (contracted to PPD Development, Wilmington, NC) Raleigh, NC (3/2002-9/2002)
Clinical Research Associate I
Therapeutic areas – digestive system (gastroephogeal reflux disease (GERD))
Monitored a late state development division on a Phase IIIb protocol study
Performed and coordinated all aspects of the in-house clinical monitoring process in accordance with GCPs and global SOPs
Telemonitored sites to ensure protocol and regulatory compliance and prepared required documentation
Represented PPD in the global medical research community and developed collaborative relationships
Liaison with investigative site personnel, and provided assistance through recruitment, pre-study, regulatory process, initiation, study start-up, study maintenance, query resolution, and study close-out
Project Renewal, New York City, NY (9/1994 –10/2001)
Senior Case Manager/M.I.C.A. Specialist (5/2000 –10/2001)
Worked as part of a multidisciplinary team, in a level II NY/NY residence, composed of RNs, psychiatrists, and CSWs to assist and treat people with severe and persistent mental illness
Managed a case load of 15, performed psychological tests, and assisted with employment, counseling, and supervision
Wrote chart notes, psychosocial evaluations, and ran groups
Oversaw the entire residence, created a format for groups, running groups, and performed individual counseling around substance abuse issues
Created a new MICA screening tool to assess substance abuse and psychiatric illness for new incoming residents
Created other assessment tools to gauge progress in groups and individual counseling sessions
Supervised and taught MSW and MA psychology level students in conjunction with their accredited university
Provided psychological counseling to patients with severe and persistent mental illness
Psychiatric Outreach Worker (9/1998 –5/ 2000)
Worked as part of a team that offered help to mentally ill and alcohol and drug abusive homeless people
Provided help to clients to move from the streets into drug and alcohol programs, psychiatric treatment, supportive services, hospitalization when needed and assistance towards placement and stability in the community
Wrote psychosocial evaluations, filled out 1995 and NY/NY housing applications, and wrote case notes
Provided ongoing support and encouragement to a highly mentally ill and resistant population
Psychiatric Outreach Team Leader (1/1997 –9/ 1998)
Supervised a BA/BSW level Psychiatric Outreach Worker and a driver
Responsible for meeting quotas, psychosocial evaluations, case notes, follow-ups, housing placements, hospitalizations, and servicing clients for the team
Responsible for providing on-going case management services while under the supervision of a CSW Director of Mental Health
Psychiatric Outreach Worker (9/1994 –1/1997)
Worked as part of a team that offered help to mentally ill, alcohol, and drug abusive homeless people
Provided help to clients to move from the streets into drug and alcohol programs, psychiatric treatment, supportive services, hospitalization when needed and assistance towards placement and stability in the community
Wrote psychosocial evaluations, filled out 1995 and NY/NY housing applications, and wrote case notes
Provided ongoing support and encouragement to a highly mentally ill and resistant population
Education
New School University Graduate Faculty
New York, NY MA – Psychology (Clinical)
Boston University
Boston, MA BA – Philosophy/Psychology (Double Major)
Languages
English
Additional Information:
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Reference:
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Candidate Contact Information:
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