Clinical Research Manager Resume Samples

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Clinical Research Managers carry both administrative and medical duties during clinical trials: overseeing daily activities, recruiting staff, implementing policies, budgeting, maintaining supplies, and attending meetings. Based on our collection of resume samples, those interested in a Clinical Research Manager position should demonstrate medical management expertise, leadership, organizational skills, accuracy, and time management. At least a Bachelor's Degree in a relevant field should be mentioned on an eligible Clinical Research manager resume. Training in study areas such as ethics, healthcare management and case management are required.

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1

Senior Clinical Research Manager

Oversee scientific testing and financial affairs to support clinical trials. Manage all biochemical assays, training and development of staff (including research assistants), laboratory operations, and budgeting/accounting. Verify and enforce
compliance with quality control guidelines and IRB rules.

  • Increased yearly lab revenues by $250K - $390K by running and managing renal plasma flow (RPF) and glomerular
  • Managed a researched study that found sodium restriction was associated with an increase in OA peak and mean systolic
  • Managed a clinical trial for Vitae Pharmaceuticals that showed how VTP-27999 drug slowed progression of chronic
  • Participated in the creation of an abstract appearing in the Journal of the American Society of Nephrology
Candidate Info
17
years in
workforce
6
years
at this job
BS
Biotechnology
MA
Biotechnology
2

Clinical Research Manager

Duties included review and total management of Phase II-IV clinical trials along with novel throm- bolytic PI research.

  • Provided cardiac healthcare to 2.8 million people by six independent physician run cardiac groups.
  • 24 hour on call status, code management while awaiting emergent cardiac intervention and coordi- nation of incoming acute cardiac patients from rural areas.
  • Designed and conducted original research evaluating women's cardiac health. Research accepted for presentation by The American College of Cardiology and The American Heart Association.
Candidate Info
14
years in
workforce
4
years
at this job
C
Certificate
C
Certificate
BSN
Bachelor of Science in Nursing
3

Clinical Research Manager/project Manager

Managed 3 international Phase One studies, 8 Phase One studies and 2 Phase 3 studies

  • Initiated and facilitated Phase 1-3 studies domestic and international
  • Contributed in collaboration with the Project Leader for the development and maintenance of the Clinical Development Plan
  • Worked with Safety Department in reconciling safety data
  • Managed Lead CRA and /or CRO in their conduct of the day-to-day operations of clinical studies including the drafting of protocols, operations manuals, CRFs, informed-consent form, and other documentation required for regulatory submissions.
  • Reviewed data query resolution, tables and listings review, and final study report from various vendors contracted to facilitate clinical trials.
Candidate Info
17
years in
workforce
2
years
at this job
BS
Nursing
4

Clinical Research Manager

Initiated all aspects of the clinical trials department for the private general oncology practice of thirteen physicians.

  • Provided clinical trial communications, regulatory compliance and contract/budget negotiation.
  • Coordinated, monitored and managed all activities of nursing, pharmacy, accounting, administrative and supportive staff in accordance with Good Clinical Practice guidelines.
  • Participated in international investigator and coordinator meetings throughout the country.
  • Collaborated with advanced practice nurses and physicians while conducting pre-study visits, staff orientation, study start-up, drug accountability, patient screening and data collection; enrollment follow-up, data entry, query resolution, study closure and reimbursement while maintaining strict HIPAA regulations.
  • Oversaw all trials conducted directly with pharmaceutical companies as well as in partnership with McKesson Pharmaceuticals U.S. Oncology Research and the Midwest Melanoma Partnership.
Candidate Info
16
years in
workforce
2
years
at this job
BS
Nursing
MS
Womens And Childrens Health Nursing
5

Clinical Research Manager

Developed and implemented standard operating procedures (SOPs) in 20 study sites.

  • Managed clinical research protocols, assured compliance with federal and local regulatory and clinical agencies and Institutional Review Boards (IRBs); assured safety and wellbeing of study participants.
  • Conducted site monitoring visits to ensure clinical aspects of study were carried out in accordance with the protocol and Good Clinical Practice (GCP) guidelines.
  • Identified, recruited and managed clinical partners and external vendors including biorepositiories.
  • Developed project metrics and budget; tracked progress and expenses.
  • Prepared study progress reports. Developed and implemented risk mitigation processes.
  • Trained and certified study staff; supervised research staff.
Candidate Info
18
years in
workforce
1
year
at this job
PhD
Nutrition / Epidemiology
Biochemistry / Biology
Nutrition / Epidemiology
6

Clinical Research Manager/coordinator

Played a key role in planning and executing Phase I, II and III Pulmonary drug trials - National Heart
Lung and Blood Institute- Acute respiratory distress syndrome (ARDS) network trials (SAILS trial,
feasibility study of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells) Sponsor trials
(ALTOR- ALT 836) and PI-initiated drug studies (EALI and LIPS A)

  • Established reputation as high performer in implementing the clinical trials
  • Led the successful implementation of complex study protocol, including the precise and comprehensive details of the trial. Met increased responsibilities with timely and accurate completion of required study and regulatory documentation.
  • Determined the inclusion and exclusion criteria and screen for potential unanticipated adverse events from the protocol by reviewing and analyzing hospital charts of complicated critically ill patients
  • Reviewed and maintained accurate billing and provided input to the study budget
  • Facilitated training and delivered in-service presentations to the intensive care unit (ICU) and on the floor nurses, Pulmonologists, Fellows and other Critical Care Doctors
  • Ensured proper maintenance of regulatory compliance in coordination with center, IRB and FDA
  • Created and updated the drug accountability log
Candidate Info
5
years in
workforce
2
years
at this job
AS
Associate of Science
BA
Medical
Education
7

Clinical Research Manager

Played a major role in restructuring the research department and establishing procedures, including the development of Standard operating procedures, and infrastructure per regulations

  • Served as head of the department from march 2011 and supervised a team of four coordinators and two interns
  • Procured several new trials for the site through diligent research and persistent networking.
  • Negotiated budget and contracts with sponsors
  • Worked closely with IRBs at several stages of study for approvals, change of status notifications and deviation reporting
  • Monitored regulatory and subject binders since mar/2012 in order to make sure site and sponsor SOPs are being followed in addition to FDA guidelines
Candidate Info
7
years in
workforce
2
years
at this job
HS
Computer Operations
MS
Life Sciences
Drug Development, Ich-gcp, Pharmacology, Clinical Research Data Monitoring
8

Clinical Research Manager

Directed over 20 research staff including clinical research coordinators, research associates and MA/lab personnel

  • Marketed studies to the community, service organizations and clinics
  • Developed a transition program from current practices towards the FDA's risk management monitoring program
  • Designed an employee skills matrix for analysis of employees and skills required to satisfy new research projects
  • Researched scientific data bases for appropriate available research studies which matched corporate skill sets
  • Created matrix reports that analyzed productivity, participant study ratios and financial contribution
  • Current GCP training
Candidate Info
30
years in
workforce
1
year
at this job
BA
Science
MA
Master of Arts
9

Clinical Research Manager- Program in Neurobehavioral Therapeutics/clinical Trials Coordination Center

Created and executed recruitment plans, determined and secured trial logistical needs in terms of staff, space and external resources, accountable to sponsor and PI for meeting established goals, responsible for IRB requirements for multiple protocols.

  • Coordinated Alzheimer’s disease prevention trial with over 400 participants for 6 years
  • Recruitment involved mail or telephone contact with over 600,000 prospects, generated database used for recruitment in subsequent studies.
  • Forged positive collaborative relationships with Departments of Radiology, Neurology, Imaging Sciences, Brain/Cognitive Sciences to facilitate participation in the Alzheimer Disease Neuro-imaging Initiative (ADNI).
  • Highest enrolling site for Alzheimer Disease Cooperative Study (ADCS) Prevention Instrument Protocol study generating ~ $600K for program.
  • Developed highly successful recruitment strategies, fastest enrolling site on multiple trials with high retention rates.
  • Initiated African American outreach program, which resulted in increased minority participation in research studies.
  • Coordinated with local Alzheimer’s Association around referrals and support for study participants/families.
  • Ensured timely and accurate data collection, responded to sponsor audits and created corrective action plan if needed
  • Oversaw 40 North American research sites for Huntington Disease clinical trial.
  • Wrote press releases and organized teleconferences when study results were made public.
Candidate Info
14
years in
workforce
3
years
at this job
BA
Psychology
MA
Clinical Social Work
MA
Business Administration- Marketing, Operations
10

Clinical Research Manager

Managed 26 clinical employees

  • Designed and implemented a new clinical research model to allow for better workflow of documents, staff responsibilities, and patient care
  • Research model also improved staffing needs of new and existing studies, the tracking and reviewing of testing results for sponsor studies
  • Developed and monitored annual budgets for seven departments
  • Reconciled monthly expenses and income for income for clinical research department
  • Oversaw daily patient care, dispensing of study drug to subjects and monitoring drug accountability for sponsors
Candidate Info
12
years in
workforce
2
years
at this job
Nursing Licensed

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